Lab Medical International Vol.28.8-9

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W O R L D S C L I N I C A L L A B O R AT O RY N E W S L E A D E R
ISSN 1068-1760 Vol. 28 No. 5 8-9 / 2011
DAILY CLINICAL LAB NEWS
Biochemical Test for Alzheimers Diagnosis
New Prostate Cancer Diagnostic Improves Over Conventional PSA Test

new test for prostate cancer that measures levels of prostate specific antigen (PSA) as well as six specific antibodies found in the blood of men with the disease is more sensitive and more specific than the conventional PSA test used today, according to a new study.
Molecular Test for Sexually Transmitted Parasite

molecular based assay that detects the protozoan parasite, Trichomonas vaginalis, has received official approval for use in clinical laboratories. The assay is an in vitro qualitative nucleic acid amplification test (NAAT) that utilizes target capture, chemiluminescent probe
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n innovative biochemical test has been designed that can identify a brain hormone in the blood of patients with Alzheimers disease (AD). A clinical study has shown that a noninvasive blood test, based on a biochemical process, may be successfully used to diagnose
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Researchers at the University of California Los Angeles (UCLA; USA; www.ucla.edu) developed the new test, called the A+PSA assay, which checks simultaneously for PSA and antibodies to six prostate-cancer associated antigens in a single reaction test done in a laboratory.
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Gene Expression Test Targets Breast Cancer Recurrence
Salivary Immunoassay Diagnoses Dengue Fever
multigene expression assay of tumor tissue is set to help doctors decide the prognosis and treatment of breast cancer. The new test could spare unnecessary chemotherapy for women whose breast cancer spread to as much as three lymph nodes.
See article on page 8
V I S I T
n antigen capture technique has been used to test the saliva of febrile patients for the presence of dengue virus (DENV) antibodies. This assay, which detects the specific immunoglobulin A (IgA) of DENV in salivary samples, has been evaluated in the early phases of a dengue infection.
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INSIDE
Image: Scanning electron micrograph (SEM) of a breast cancer cell
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POC Immunoassay Analyzer Detects Venous Thromboembolism
compact and cost-effective point of care (POC) immunoassay analyzer offers rapid turnaround times for the determination of critical biomarkers, such as D-dimers, and provides
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Clinical News . . . . . . . 2-42 IFCC News . . . . . . . . . . 43 EFCC Corner . . . . . . . . . 46 Product News . . . . . 18-38 Technical Literature . . . 40 Industry News . . . . . . . . 49 International Calendar . 50
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Tuberculosis Test to Serve Developing World
Prenatal Test Identifies Trisomy 21 and Trisomy 18
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molecular diagnostic test for tuberculosis (TB) has proven to be both effective and rapid in countries in the developing world that are endemic for the disease. The assay is a real time polymerase chain reaction (rt-PCR) amplification test that simultaneously
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prenatal test accurately identified multiple fetal chromosomal abnormalities from maternal blood. In a study carried out in 13 US clinics a classification algorithm was developed using the prenatal test that correctly classified all trisomy 21 and trisomy 18 test samples.
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Molecular Test for Sexually Transmitted Parasite

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Image: Scanning electron micrograph (SEM) of Trichomonas vaginalis, the human parasitic flagellate that causes the sexually transmitted disease trichomoniasis (Photo courtesy of David M. Phillips / SPL).
hybridization that detect ribosomal ribonucleic acid (rRNA) from T. vaginalis. The assay is designed to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs and vaginal swabs, female urine specimens, and specimens collected in specific transport solution. The assay utilizes Target Capture, TranscriptionMediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies When the APTIMA Trichomonas vaginalis Assay (Gen-Probe Incorporated, San Diego, CA, USA; www.gen-probe.com) is performed, the target rRNA is isolated from the specimen by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific
regions of the T. vaginalis rRNA target molecules as well as a string of deoxyadenosine residues. During the hybridization step, the sequence-specific regions of the capture oligomers bind to specific regions of the T. vaginalis rRNA target molecule. The capture oligomer target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. The assay is used on the fully automated TIGRIS system, which is also manufactured by GenProbe. Carl W. Hull, MBA, Gen-Probes president and CEO, said, Our assay will provide a convenient tool for physicians and laboratories because it employs the same technology as our market-leading tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system. The APTIMA Trichomonas assay has been cleared for marketing by the US Food and Drug Administration, (FDA, Silver Springs, MD, USA; www.fda.gov). T. vaginalis is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women. If left untreated, complications can include premature labor, low-birth-weight offspring, and premature membrane rupture in pregnancy. The US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA; www.cdc.gov) estimate that 7.4 million American men and women are infected with this parasite annually.
POC Immunoassay Analyzer Detects Venous Thromboembolism

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a valuable diagnostic tool for ruling out venous thromboembolism (VTE). The easy-to-use AQT90 FLEX can simultaneously measure cardiac markers, coagulation markers, infection markers, and pregnancy markers from a single sample. No sample preparation is required, and, as a closed tube system, the risk of users coming into contact with blood or waste products is eliminated. A product of Radiometer (Crawley, United Kingdom; www.radiometer.co.uk), the compact, costeffective AQT90 FLEX enables clinicians to perform rapid, accurate, POC D-dimer measurements in less than 20 minutes. AQT90 FLEX delivers complete data capture with continuous synchronization of analyzers and laboratory information systems/hospital information systems (LIS/HIS). The Radiance software solution provides complete remote control that emulates the data control and flow of a central laboratory, with the potential to encompass multiple hospitals within a region. Reports have estimated that 25,000 people die annually as a result of VTE, and that more than 10,000 lives could be saved if all patients were screened on admission to hospital. Patients with negative D-dimer test results are at very low risk of VTE. Rapid point-ofcare testing with the AQT90 FLEX saves time and reduces costs by improving patient flow and decreasing the number of unnecessary procedures requested.
LabMedica International August-September/2011
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LabMedica
Salivary Immunoassay Diagnoses Dengue Fever

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EDITORIAL BOARD
Rosa I. Sierra-Amor Mexico Robby Bacchus United Kingdom Edward J. Bottone United States Claus Christiansen Denmark Bernard Gouget France Anders Kallner Sweden Tadashi Kawai Japan John A. Koepke United States John B. Lines United Kingdom Donald Moss United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Grard Siest France Andrew Wootton Australia
A GLOBETECH PUBLICATION
Scientists at the Environmental Health Institute, Singapore National Environment Agency (Singapore, Singapore; www.nea.gov.sg) have developed an antigen capture anti-DENV IgA (ACA) enzyme-linked immunosorbent assay (ELISA) technique for the diagnosis of dengue fever. They collected 69 saliva samples from dengue-confirmed patients at three time points, using Oracol saliva collection swabs (Malvern Medical Development Ltd., Barbourne UK; www. malvernmedical.uk.com). Blood samples were collected at the same time. The ACA-ELISA on saliva had an overall sensitivity of 70% in the first three days after fever onset and subsequently rose to over 90% between the third day and eighth day following fever onset. The same technique on sera gave similar results. The sensitivity of ACA-ELISA in saliva was higher than that of the PanBio immunoglobulin M (IgM) Capture ELISA (Alere Inc., Waltham, MA, USA; www.alere.com), on sera. The IgM assay detected only 10% of the dengue-confirmed patients after one to three days of fever, and only rose to around 90% after six days of fever. The specificity of the ACA-ELISA test was also found to be high at 97%. Among the 75 DENV-negative control patients, only one patient tested positive, at day seven and day 27, respectively. The investigators noted that the saliva assay eliminates the need to collect blood from dengue-suspected patients and is painless, nonintrusive, and reduces the risk of needle stick injury. Moreover, the ELISAbased technique is simple and cost effective. Patients,
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especially the very young and the old, will be more willing to undergo a dengue test. Together, these benefits can potentially improve surveillance and early detection of cases, which in turn can translate to prompt dengue control effort. Due to its high sensitivity among secondary dengue infections, this technique could be very useful in highly endemic areas where the majority of the dengue cases are secondary. Dengue fever is the most common identifiable cause of acute febrile illness among travelers returning from South America, South Central Asia, Southeast Asia, and the Caribbean. The study was published online on May 10, 2011, in the Public Library of Science (PLoS) journal Neglected Tropical Diseases.
Image: Colored transmission electron micrograph (TEM) of dengue fever virus particles (blue) in a cell (Photo courtesy of Science Photo Library).
Dan Gueron Jill Roberge Jacqueline Miller, PhD Raymond L Jacobson, PhD Jerry Slutzky, PhD Andreas Rothstein Marcela Jensen Joseph Ciprut Brenda Silva Paul Mills Doris Mendieta Renata Castro Dr. Jutta Ciolek Christina Chang Arda Turac Elif Erkan
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Prenatal Test Identifies Trisomy 21 and Trisomy 18

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Verinata Health, Inc. (St Carlos, CA, USA; www. verinata.com), a privately-held company dedicated to maternal and fetal health, developed the prenatal test, which uses massively parallel DNA sequencing of cell
free fetal DNA from maternal blood. For the study, blood samples were collected from 1,014 pregnant women at 13 US clinic locations prior to an invasive prenatal procedure (chorionic villus sampling (CVS), or amniocentesis). Samples were selected for use as training or test samples. From the 119 samples selected for the study, cell-free DNA (cfDNA) was extracted from the maternal plasma and the cfDNA was sequenced using massively parallel sequencing. Sixtyfive of the samples were used as a training set to define a classification algorithm that was able to identify correctly 100% of trisomy 21 and trisomy 18 samples in an independent test set. The algorithm also detected trisomy 9 in one test sample as well as the presence of trisomy 21 in two sets of twin pregnancies having at least one affected fetus. All 47 test samples were correctly classified for the autosomes and sex chromosomes. Lawrence W. Platt, MD, professor of obstetrics and gynecology at the David Geffen School of Medicine at the University of California Los Angeles (UCLA; USA; http://healthsciences.ucla.edu) and director of the center for fetal medicine and Womens Ultrasound in Los Angeles, remarked, As the standard of practice is now to offer prenatal diagnosis to all of our patients, independent of age, the need for noninvasive diagnostic testing for chromosomal abnormalities without risk of miscarriage continues to be one of the highest priorities in diagnostic testing. Results of the study appeared online in the April 2011 issue of Clinical Chemistry.
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ISSN 1068-1760
Vol.28 No.5. Published, under license, by Globetech Media LLC; Copyright 2011. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services.
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Tuberculosis Test to Serve Developing World
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Image: Colored scanning electron micrograph (SEM) of a macrophage white blood cell (purple) engulfing a tuberculosis (Mycobacterium tuberculosis) bacterium (pink) (Photo courtesy of Science Photo Library).
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detects rifampicin resistance and is used in conjunction with an automated platform, which integrates sample processing and greatly simplifies testing. A multicenter study is being conducted under the auspices of the Foundation for Innovative New Diagnostics (FIND; Geneva, Switzerland; www. finddiagnostics.org). South African participants at the University of Cape Town (Cape Town, South Africa; www. uct.ac.za), and others from Peru, India, Azerbaijan, the Philippines, and Uganda, enrolled 6,648 eligible adults. The study groups were all aged 18 years or older, with at least two weeks of cough who presented consecutively to urban or periurban primarycare health centers from August 11, 2009, until June 26, 2010. The primary impact outcomes assessed were the time between the first presentation to clinic of a patient with symptoms and the start of appropriate treatment for TB and, secondly, the proportion of patients in each site with undiagnosed TB, two months after the first TB test. The rt-PCR assay is an automated cartridge based diagnostic system, known as the Xpert MTB/RIF, and was developed for the GeneXpert platform (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). The test correctly detected tuberculosis in more than 90% of patients with positive cultures, with a 99% specificity for nontuberculosis samples. Performance was much the same during validation and implementation phases. A onetime MTB/RIF test identified significantly more cases of tuberculosis than did 2-3 smear microscopy examinations per patient, which detected 699 of 1,041 culture-positive patients and 3,700 of 3,718 patients without tuberculosis. The sensitivity of the MTB/RIF assay was not significantly affected by human immunodeficiency virus (HIV) coinfection status, which significantly decreased the sensitivity of smear microscopy. The authors concluded that overall, their findings suggest that decentralized MTB/RIF test implementation is feasible and could lead to an improvement in tuberculosis care and control. Any improvement will require increased detection of tuberculosis and multidrug-resistant-tuberculosis to coincide with scale-up of first-line, and more importantly, second-line treatment. Whether early and appropriate treatment after MTB/RIF testing can reduce tuberculosis-associated morbidity and mortality, and its effect on transmission, still needs to be established. The study was published on April 30, 2011, the Lancet.
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LabMedica
Gene Expression Test Targets Breast Cancer Recurrence
multigene expression assay of tumor tissue will help doctors decide the prognosis and treatment of breast cancer. The test measures the expression or activity level of 21 specific genes within a tumor sample and based on that pattern assigns a recurrence score of anywhere from 0 to 100. Earlier trials have shown that the higher the recurrence score, the more likely the patients cancer will recur. Scientists, specializing in cancer, have launched a clinical trial that could keep thousands of breast cancer patients from getting chemotherapy that is unlikely to do them any good. The trial will reveal whether chemotherapy benefits patients with node positive breast cancer who have low to intermediate Oncotype DX recurrence scores. The trial also seeks to determine whether there is an optimal recurrence score cut-
point for these patients, above which chemotherapy should be recommended. The scientists plan to enroll 4,000 women with recurrence scores of 25 or less who have early stage, hormone receptor-positive, HER2-negative breast cancer that has been found to involve one to three lymph nodes. They expect to screen about 9,000 breast cancer patients in order to register these 4,000, who will be randomized to receive either chemotherapy with endocrine therapy or endocrine therapy alone. The Oncotype DX assay is a product of Genomic Health Inc. (Redwood City, CA, USA; www.genomichealth.com), and is only one of several gene expression profile tests oncologists now use to help them judge how likely it is a patients cancer will return or to inform treatment decisions. The investigators plan to evaluate other
tests as well, including the PAM50 test, which measures the expression level of a set of 50 genes to determine a patients risk of recurrence score. The PAM50 (ARUP Laboratories, Salt Lake City, UT, USA; www.aruplab.com) uses a reverse transcription/quantitative polymerase chain reaction on formalin fixed paraffin embedded tissue. Ana M. Gonzalez-Angulo, MD, the study coordinator from the MD Anderson Cancer Center (Houston, TX, USA; www.mdanderson.org), said, If the treatment (Rx) for Positive Node, Endocrine Responsive Breast Cancer (RxPONDER) trial confirms findings from earlier studies, it will mean that we know more precisely how to use a genomicbased test to spare thousands of women whose breast cancer has spread to as many as three lymph nodes, the grueling side effects and staggering costs of chemotherapy they do not need.
Biochemical Test for Alzheimers Diagnosis

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Alzheimers at an early stage and differentiate it from other types of dementia. Scientists at McGill University Health Center (MUHC; Montreal, QC, Canada; www.muhc.ca) based the Alzheimers blood test on the production of a brain hormone called dehydroepiandrosterone (DHEA). This hormone is present at high levels in the brain where it has a wide range of biological effects. A total of 86 subjects were included in this study: 19 male and 20 female AD patients; 18 male and 22 female age-matched controls; and 4 men and 3 women with mild cognitive impairment. The scientists were able to promote the
production of DHEA, using a chemical process called oxidation, in blood taken from non-Alzheimers patients. However, serum oxidation, by way of ferrous iron (Fe2+), on the blood from Alzheimers patients did not result in an increase of DHEA. Currently the diagnosis of Alzheimers follows the sequence of family history, information, mental assessment and the physical exam, focusing on neurological signs. Vassilios Papadopoulos, D.Pharm., PhD, a lead author of the study, said, There is a clear correlation between the lack of ability to produce DHEA through oxidation in the blood and the degree of cognitive impairment found in Alzheimers disease.
We demonstrated we could accurately and repetitively detect Alzheimers disease, with small samples of blood. This test also allowed for differential diagnosis of early stages of Alzheimers disease, suggesting this can be used as a test to diagnose the disease in its infancy. Professor Papadopoulos believes that an accurate, easy, and specific noninvasive biochemical test that correlates with clinical findings is vital. The results of the study demonstrate that the DHEA-oxidation blood test can be used to diagnose AD at a very early stage and monitor the effect of therapies and the evolution of the disease. The study was published in April 2011, in the Journal of Alzheimers Disease.
New Prostate Cancer Diagnostic Improves Over Conventional PSA Test

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The six specific prostate-cancer associated antigens include NY-ESO-1, SSX-2,4, XAGE-lb, AMACR, p90, and LEDGF, which are found predominantly in patients with prostate cancer and not in benign prostate conditions. The new test takes about two hours, similar to the PSA test. The test results in an index used to diagnose prostate cancer, with a score
of 0-0.5 indicating a benign result and 0.5-1 indicating the presence of cancer. In the new test, sensitivity the percentage of men with prostate cancer who were correctly identified as having a malignancy was 79%, compared to the 52% found in PSA testing. Specificity the percentage of healthy men who were correctly identified as not having prostate cancer was 84%, compared to the 79% found when
testing for PSA alone. Additionally, while the rate of false-positives using conventional PSA testing is 21%, the new A+PSA assay delivers a false-positive rate of 16%. The study was published in the May 2011 issue of Translational Medicine. Science has improved so much since the PSA test was developed and I think its time for a more specific and sensitive test to be developed, said senior author Gang Zeng, MD, PhD, an associate professor of urology. I think we have a test that has great potential to improve the diagnosis of prostate cancer. I knew it would be better than the classic PSA test, but I was amazed at how much better it really was in this study. While measuring PSA is useful in identifying men with prostate cancer, some men with prostate cancer have a normal PSA level and small elevations in PSA above normal may be produced both by prostate cancer as well as an enlarged but benign prostate, added coauthor associate professor of urology Allan Pantuck, MD, MS. Combining PSA with a panel of tests that measure an individual mans anticancer immune response may better identify who has prostate cancer and who can be spared an unnecessary invasive biopsy. The conventional PSA test for prostate cancer has been used for nearly 30 years and is not specific enough in delineating between malignancies and nonmalignant diseases of the prostate, such as benign prostatic hyperplasia (BPH), an enlarging of the prostate common in aging men that increases PSA levels.
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LabMedica
Blood Culture Test Optimizes Antimicrobial Therapy
bacteriophage amplification platform enables early identification of Staphylococcus aureus and determination of antibiotic resistance or susceptibility. The blood culture test enables clinicians to optimize therapy by identifying S. aureus directly from Gram-positive blood cultures and determine antibiotic susceptibility on the same day. The KeyPath MRSA/MSSA Blood Culture Test can determine methicillin resistance (MRSA) or susceptibility (MSSA) of the bacteria far faster than standard antibiotic susceptibility testing. The test, which takes a little over five hours to get a result, is 98.9% accurate (178/180) for MRSA identification and 99.4% accurate (153/154) in determining MSSA within the organisms identified as S. aureus. As many as half of all patients with S. aureus infections are initially prescribed inappropriate or suboptimal antibiotics before traditional test meth-
ods return information about the bacterias antibiotic susceptibility. The KeyPath test provides crucial diagnostic information that enables doctors to prescribe the most appropriate antibiotics for a patients infection up to two days sooner than is possible with current test methods. The KeyPath MRSA/MSSA Blood Culture Test is a product of MicroPhage, Inc. (Longmont, CO, USA; www.microphage.com). The test, developed using MicroPhages proprietary Bacteriophage Amplification Technology (BAT) platform, meets the Clinical and Laboratory Standards Institute (CLSI; Wayne, PA, USA; www.clsi.org) and US Food and Drug Administration (FDA; Silver Springs, MD, USA; www.fda.gov) criteria. Drew Smith, PhD, chief science officer at MicroPhage, said, The MicroPhage BAT platform
provides a phenotypic result that directly assesses the organisms response to an antibiotic. The platform can be extended to a broad range of bacterial pathogens and sample types thus enabling development of a long pipeline of clinically useful susceptibility tests and test panels.
Image: The KeyPath MRSA/MSSA blood culture test (Photo courtesy of MicroPhage).
Bacterial DNA Sequenced from Cystic Fibrosis Patients
he DNA from a bacterium that is the most common cause of persistent and fatal lung infections in cystic fibrosis patients has been sequenced. Molecular technology has been utilized to characterize the organism, called Pseudomonas aeruginosa, and identify a particularly virulent strain found in chronic infections. Scientists at the University of Liverpool, (Liverpool, UK; www.liv.ac.uk), took samples from patients sputum and cough swabs to understand why the infection is so aggressive in people with cystic fibrosis. They used new DNA sequencing technology to read the genetic code of the infection. The technology used can read 30 billion letters of DNA sequence per day, compared to four billion using current machines. The technology allowed the scientists to investigate the mutations
of the infection in precise detail, giving them valuable information about the progress of this serious medical condition. The scientists identified a strain, called the Liverpool Epidemic Strain (LES), that can cause aggressive infection and results in progressive lung decline. This strain is referred to as a cystic fibrosis superbug. They demonstrated that the greatest contribution to the extremely high levels of diversity is within individual patient sputum samples rather than between patients, and they showed correlation between greater prevalence of a virulencerelated phenotype and acute pulmonary symptoms. They found that during chronic infections P. aeruginosa has the ability to mutate rapidly, resulting in extensive diversity in the bacterial population. Tests also showed that when the bacteria have an overproduction of pyocyanin, a quorum-sensing-con-
trolled virulence factor, this could be the trigger for episodes of acute infection in patients. Craig Winstanley, PhD, a member of the Biomedical Research Center at Liverpool University, explained that patients with LES need to be separated from others in hospitals, so that infection does not spread between cystic fibrosis patients on wards. Once established, these chronic infections can never be cleared. P. aeruginosa has the ability to diversify into hundreds of distinct subtypes, making it very difficult to decide which antibiotic to use for a successful outcome. Each cystic fibrosis patient can be infected with a diverse population of bacteria and it is therefore essential to test samples of the disease from a number of patients in order to understand how it evolves. The article was published on February 4, 2011, in the American Journal of Respiratory and Critical Care Medicine.
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LabMedica
Blood Culture Vials Can Be Transported Safely
system enables safe transportation of blood culture vials. The Bactec SafePod was designed for the safe transportation of blood culture vials in pneumatic tube systems, and for safe transportation of positive blood cultures from satellite sites to a central laboratory. Becton, Dickinson and Company (BD; Oxford, United Kingdom; www.bd.com) developed the SafePod, an enclosed system that was designed to accommodate up to two BD Bactec bottles, which will fit all pneumatic tube transport systems, to convey safely blood culture vials from point of collection to point of analysis. The SafePod contains an absorbent insert that separates the Bactec blood culture vials to cushion them during high-speed transportation, and is capable of absorbing 100 mL of liquidmore than sufficient for the contents of two bottles. SafePod is manufactured from clear plastic for easy inspection prior to opening, and is sterilizeable for reuse.
The BD Bactec SafePod is fully compliant with all UN 3373 transportation requirements for diagnostic blood specimens, both inside and outside the hospital. BD Bactec blood culture bottles are fully compliant as the primary receptacles, and the BD Bactec SafePod is fully compliant as the secondary receptacles. The BD Bactec bottles and the BD Bactec SafePod count as the first two layers, enabling further packaging into either a pneumatic tube for transportation within the hospital, or a rigid box for transportation within sites. Chris Head-Jenner, Marketing Manager, UK and Ireland, BD, who led the product design, says, Historically, there has been a reluctance to transport biological compounds in glass bottles through hospital pneumatic tube systems, for
fear of breakage. The BD Bactec SafePod addresses these customer concerns by providing a system that safely transports biological compounds, meets HPA requirements, whilst also saving space and time.
Image: The Bactec SafePod for transportation of blood culture vials (Photo courtesy of BD).
Fluorescent Assay Determines Free DNA in Cancer Patients Serum
n assay has been developed that measures circulating cell-free DNA in the serum of patients with cancer using a fluorochrome, and without extraction and amplification. The assay is simply performed by adding diluted fluorochrome to the samples and measuring the fluorescence obtained. The assay is accurate, sensitive, and reproducible. The assay was developed at the Soroka University Medical Center, (Beer Sheva, Israel; www.soroka.org) and compared with a commercial kit for carcinoembryonic antigen (CEA). The innovative fluorescent assay was first evaluated on a mouse model and then tested on colorectal cancer (CRC) patients serum. There were 38 unselected patients with confirmed primary CRC recruited among whom 55% were women and 45% were men. The age range was 43-86 years, and the mean
age was 68 years. The primary colon carcinoma sites were as follows: right colon, sigmoid colon, left colon, rectum, and simultaneous carcinoma in the right and left colon. Serum from healthy volunteers was also tested. The concentration of CEA was determined by using the ARCHITECT CEA assay (Abbott Laboratories, Abbott Park, IL, USA; www.abbott.com). The cell-free DNA (CFD) assay used diluted SYBR Gold Nucleic Acid Gel Stain (Invitrogen; Carlsbad, CA, USA; www.invitrogen.com), which was added to the serum samples and the resulting fluorescence measured with a 96-well fluorometer. Concentrations of unknown samples were calculated from a DNA standards curve by extrapolation in a linear regression model. The 38 patients with CRC had higher preoperative CFD levels of 798 409 ng/mL, when compared with healthy subjects
with CFD levels of 308 256 ng/mL. CFD levels were elevated in patients who remained with the disease or died as compared with patients free of disease at one year. Colorectal cancer (CRC) is the third most common type of cancer worldwide, with an estimated one million new cases and a half million deaths each year. Early diagnosis is fundamental in reducing morbidity and mortality, with patients diagnosed at early stages demonstrating increased long-term survival. The authors concluded that by using a simple fluorometric assay, they were able to find elevated CFD levels in cancer patients, confirming the findings of previous studies that were performed with a complex and time-consuming method. The study was published in February 2011, in the American Journal of Clinical Pathology.
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LabMedica
Molecular Test Increases Specificity for Human Papillomavirus

hree different tests have been compared for the detection of human papillomavirus (HPV) on cervical specimens and correlated with the presence of cancer. The tests are molecular diagnostic kits that either identify messenger ribonucleic acid (mRNA), or use hybrid capture DNA technology. A real-time multiplex nucleic acid sequencebased amplification assay (NASBA) for isothermal amplification and detection of mRNA was also compared. Scientists from the Memorial University (St. Johns, NL, Canada; www.mun.ca) collaborating with others, tested cervical specimens from a random sample of 1,418 women referred for colposcopy and assessment of cervical cancer risk and 1,373 women undergoing routine screening. The three tests were the Aptima HPV assay which detects E6/E7 mRNA of 14 oncogenic types, a Hybrid Capture 2 DNA test (HC2), and an HPV Proofer assay which amplifies and detects E6/E7 mRNA from five high-risk oncogenic types. The oncogenes E6 and E7 are associated with HPV and these proteins are involved in initiation and mediation of oncogenic process that leads to cervical cancer, and to other HPVassociated cancers. The investigators report that among 1,418 women studied, the Aptima HPV test (GenProbe Inc.; San Diego, CA, USA; www. gen-probe.com) detected 96.3% of women with high-grade cervical intraepithelial neoplasia (CIN) or worse (CIN 2+) compared to 94.3% for the HC2, (Qiagen; Mississauga, ON, Canada; www.qiagen.com). The Aptima test has far fewer false positives than HC2. Across histological grades, the Aptima assay showed significantly higher sensitivity and significantly lower specificity than the PreTect HPV-Proofer NASBA assay (Norchip; Klokkarstua, Norway; www.norchip. com), however, the Proofer test detected all eight
cases of invasive cervical cancer, and this included the case which tested negative by HC2. The authors concluded that their data indicated that the Aptima test is as sensitive as HC2, but more specific for detecting CIN 2+ and has the potential to serve as a reliable test for both primary cervical cancer screening and the triage of borderline cytological abnormalities. Samuel Ratnam, PhD, the senior author of the study, said, Reducing false-positive result avoids unnecessary additional tests and follow-up, the associated health care costs, and distress to women. HPV infection is highly prevalent, but only a small fraction of the infected is at risk of developing HPV-associated cancers. The study was published in February 2011, in the Journal of Clinical Microbiology.
Image: Colored transmission electron micrograph (TEM) of hundreds of particles (red) of the human papillomavirus (HPV) infecting a host cell (Photo courtesy of Steve Gschmeissner / Science Photo Library).
HIV-1 Qualitative Assay Improves Testing Access in Remote Areas
new qualitative polymerase chain reaction (PCR)-based Human immunodeficiency virus 1 (HIV-1) test produces highly accurate results from dried blood spot and plasma specimens. The diagnostic tool can be used by health officials in African nations and other resource-limited areas to detect HIV-1 infected infants at early stages and begin treatment when success is more likely. Abbott (Abbot Park, IL, USA; www.abbott.com) has received the CE marking for the new assay, which reports qualitative results of HIV-1 total nucleic acids from human plasma and dried blood spots. The assay is highly sensitive for detecting HIV in pediatric and adult specimens. The test is designed to aid in diagnosing HIV infection in children and adults and is not intended for screening blood donors. The assay is performed on Abbotts automated, high-throughput m2000 system. It detects both
DNA and RNA of HIV-1. Dried blood spot samples are more convenient for testing infants because only a small volume of sample is needed and the sample remains stable under various environmental conditions. Kristina Rodnikova, divisional vice president and general manager of Abbott's molecular diagnostics business in Europe said, "Early detection of infants with HIV is now more practical and possible in remote areas because a drop of blood can be applied to a paper card for HIV testing, which allows for easy collection, transport, and storage. The sample can be stored at room temperature and will remain stable for three months." The new RealTime HIV-1 qualitative assay will be available for diagnostic laboratories and supplied to nongovernmental organizations (NGOs) and health agencies collaborating with the Ministries of Health in countries most affected by the epidemic.
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LabMedica
MICE Strips Expanded to Include the Antibiotic Tigecycline
he range of minimum inhibitory concentration evaluator (MICE) strips has been expanded to include the antibiotic tigecycline. MICE strips provide a gradient of stabilized antimicrobial in a convenient polymer strip format. When applied to an inoculated agar plate, the antimicrobial is released from the strip, forming a defined concentration gradient in the surrounding agar. Following appropriate incubation, the MIC value is easily read at the point where organism growth is no longer inhibited along the length of the strip. Each strip is individually foilwrapped with desiccant to maintain its integrity until use. For convenience, and to meet the needs of every laboratory, MICE strips are available in stackable boxes of 10 or 50.
The newly added tigecycline strips together with other recently added antimicrobials, including ceftazidime and amikacin, ensure that the comprehensive MICE range for the accurate determination of minimum inhibitory concentration (MIC) values meets the current needs of clinical microbiologists for antimicrobial susceptibility testing. The new MICE strips were released by Oxoid (Basingstoke, UK; www.oxoid.com), a specialty microbiology company of Thermo Fisher Scientific Inc. (Fremont, CA, USA; www.thermofisher.com).
Image: The range of M I C Evaluator ( M I C E) Strips has been expanded to include the antibiotic tigecycline (Photo courtesy of Oxoid).
miRNA Target Identification Technology Being Developed
ew technology is being developed and commercialized for the identification and validation of microRNA (miRNA) targets in clinical diagnostics and research. miRNAs are critical regulators of gene expression in eukaryotic cells, with over 1,000 different miRNAs in the human genome already known to play multiple roles in gene regulation. Although the specific targets of most miRNAs are largely unknown, aberrant expression of miRNAs has been implicated in numerous disease states, making them important targets for clinical investigation in oncology, wound healing, and infectious disease. Sigma Life Science (St. Louis, MO, USA; www.sigma-aldrich.com), the biological products and services research business of Sigma-Aldrich and Kings College London (United Kingdom; www.kcl.ac.uk) announced an exclusive license agreement to identify miRNA targets. Currently, identification of miRNA targets is laborious and inefficient, relying on computer algorithms and subsequent validation by in vitro assays. Scientists in the division of cancer studies at Kings have developed a technology allowing simple, accurate identification and validation of miRNA targets. Dr. Joop Gaken, lead investigator of this project, explained: The role of miRNAs in cancer is well established, and several miRNAs clearly function as either oncogenes or tumor suppressor genes, although the target genes are unknown in the majority of cases. This new test is expected to enable the straightforward identification of target genes that are strongly regulated by a given miRNA, helping to elucidate important gene regulation events in vivo.
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Candida Rapidly Detected by Magnetic Biosensor Test
magnetic biosensor test detects the fungal pathogen Candida directly in whole blood from patients with the fungal infection. The new technology enables detection of multiple pathogens and species in a single-process test with rapid diagnostic results within minutes to less than two hours. Developed by T2 Biosystems (Lexington, MA, USA; www.t2biosystems.com), magnetic biosensor technology combines nanotechnology with the power of magnetic resonance detection. A dirty sample of a patients blood, saliva, urine, or other biofluid is loaded directly into a desktop instrument via a disposable cartridge. The sample is then mixed with magnetic nanoparticles and analyzed for the presence of specific fungal, bacterial, or viral pathogens, or biomarkers using a technique similar to magnetic resonance imaging
(MRI). The system is able to detect low concentrations of target agents or specific pathogens. In comparison, todays conventional diagnostic technologies use optical signals, require preprocessed biologic samples, and can take days to yield useful results. Candidemia, a systemic fungal infection that occurs when Candida organisms are present in the blood, is a potentially life-threatening bloodstream infection. Each year, an estimated 60,000 patients contract Candidemia in the United States alone and this incidence continues to rise. It is the most deadly of the common hospital-acquired bloodstream infections, and currently results in significant increased hospital stays, healthcare costs, and patient mortality. T2 Biosystems, Inc., a company developing next generation diagnostic products, presented
data on the rapid and sensitive detection of five Candida species (C. albicans, C. krusei, C. glabrata, C. tropicalis, and C. parapsilosis) at the Annual Meeting of the Mycoses Study Group in Philadelphia (PA, USA) on April 7, 2011.
Image: Colored scanning electron micrograph (SEM) of budding threads (hyphae) of a Candida fungus (Photo courtesy of Steve Gschmeissner / SPL).
Oncology Testing Service Utilizes New Microarray Technology

n oncology testing service utilizes a new microarray technology to aid in the faster, earlier, and more accurate diagnoses of hematological malignancies. The OncoChip offering is among the very first microarrays that can detect balanced translocations, their partners, and their breakpoints associated with the hematological malignancies. PerkinElmer, Inc. (Waltham, MA, USA; www. perkinelmer.com) Signature Genomics Laboratories introduced the new service, which quickly identifies chromosome abnormalities to aid in cancer patient diagnosis and prognosis. The results of the OncoChip microarray technology may allow for more targeted, rapid, and accurate treatments of patients with hematological cancers, such as chronic lymphocytic leukemia, chronic myelogenous
leukemia, acute myeloid leukemia, T-cell and B-cell acute lymphoblastic leukemia. Clinicians can select from a broad menu of cancer-specific panels that will be run by PerkinElmers Signature Genomics Laboratories, using software applications that have been designed to allow for customization suiting the needs of each individual patient. Two distinct OncoChip microarray options are offered by PerkinElmer Copy Number Evaluation (CNE) and Translocation Assessment (TA). CNE detects all clinically relevant copy-number gains and losses commonly seen by karyotype. It also measures gains and losses below the resolution of karyotyping and fluorescent in situ hybridization (FISH), providing more detailed information. The TA microarray option detects
the clinically relevant balanced translocations identified by FISH and karyotype and precisely recognizes balanced translocation breakpoints, as well as balanced translocation partners not distinguishable by these methods. Findings using OncoChip have the potential to help clarify or alter a patients diagnosis and prognosis as well as reclassify the disease. Results are provided faster, accurately, and with more clinical relevance than current standard methods, which furthers our goal to enable a more personalized approach to treatments, said Lisa G. Shaffer, PhD, president, PerkinElmers Signature Genomics Laboratories. The OncoChip also allows for the detection of even more chromosome abnormalities than has been possible previously.
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Gen-Probe
The latest microarray test is designed for rapid simultaneous detection of 25 of the most common mutations causing cystic fibrosis. The test ensures reliable detection with enhanced specificity and sensitivity, and applications include newborns through adults.
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The XI-921 features the option to run either Cl or Li on the F model (Na, K, Cl/Li). Other key features include enhanced accuracy and improved software version 7.01, along with a 12-month life span for the electrodes.
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The latest tumor marker control is intended for use as a quantitative, assayed serum control. The multiconstituent control also contains the ovarian biomarker HE4, which along with CA 125 is used to determine risk for cancer and monitor reoccurrence.
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The Panther features maximum productivity with minimal hands-on time required. Additional benefits include enhanced flexibility, a range of CEmarked assays, ease of use, and reliability of performance.
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Multiplexed NA Test Simultaneously Detects 15 Respiratory Viruses
multiplexed nucleic acid (NA) test simultaneously detects 15 respiratory viruses in one hour. The FilmArray detects viral nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The system represents a significant advancement in user friendliness and multiplex infectious disease testing capability for hospital clinical labs. It requires only two minutes of hands-on time and has a one-hour turnaround time. The following virus types and subtypes can be tested for using the FilmArray: Adenovirus, Corona-
virus HKU1, Coronavirus NL63, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1 2009, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/ Enterovirus, and Respiratory Syncytial Virus. Idaho Technology, Inc. (ITI; Salt Lake City, UT, USA; www.idaho tech.com) announced that the US Food and Drug Administration (Silver Spring, MD, USA; www. fda.gov) has issued a 510(k) clearance for its FilmArray instrument and the FilmArray Respiratory Panel.
Idaho Technology, Inc. is a privately held biotechnology company that licensed rapid PCR technology from the University of Utah. The company has additional FilmArray infectious disease applications in its
R&D pipeline, including a blood culture ID panel, gastrointestinal panel, and an STI panel.
Image: The FilmArray fully automated biodetection system (Photo courtesy of Idaho Technology).
Pneumocystis Jiroveci Assay Evaluated in Multicenter Trial
real-time polymerase chain reaction (PCR) assay of Pneumocystis jiroveci was validated in a multicenter trial. MycAssay Pneumocystis is a commercial assay that targets the MycAssay Pneumocystis that targets the P. jirovecii mitochondrial large subunit. Myconostica (Manchester, United Kingdom; www.myconostica.co.uk), a company specializing in rapid molecular diagnostic tests for life-threatening fungal infections, announced the results of the prospective trial of its CE marked kit, MycAssay Pneumocystis. The trial results compared well with clinical diagnosis using nonmolecular methods and demonstrated the high sensitivity and specificity of the PCR diagnostic assay. The multicenter trial recruited 110 subjects from a variety of underlying diseases and conditions including solid organ transplants, leukemia, solid tumors, and HIV. Respiratory bronchoalveolar sam-
ples were analyzed and 13/14 patients with clinically proven Pneumocystis pneumonia (PCP) were identified and 9/96 patients without PCP at the time of the test also gave positive results. Subsequently one of these patients developed PCP while the others were considered to be colonized with P. jirovecii. PCP is a very dangerous infection in both AIDS and non-AIDS patients with mortality rates in excess of 20%. Currently, establishing the diagnosis of PCP is performed by microscopy of lung tissue, bronchial lavage, or other deep respiratory samples. PCP primarily affects the alveoli; consequently, deep pulmonary samples are necessary for adequate microscopy. However, microscopic diagnosis, including the Merifluor-Pneumocystis direct fluorescent antigen (MP-DFA) test, has limitations. For example, a much lower number of organisms are usually present in non-AIDS patients with PCP, which makes the microscopic tests more difficult to perform and lees reliable.
Commenting on these results, Dr. John Thornback, Chief Business Officer of Myconostica commented, This is, to our knowledge, the first multicenter prospective trial of a commercial PCR test for Pneumocystis. Pneumocystis PCR is clearly a very sensitive means of detecting this fungal pathogen in at risk patients. The introduction of new technologies such as Pneumocystis PCR often results in reappraisal of disease, and this may be the case here. The early identification of infected patients may open opportunities for early interventions. Myconostica is committed to working with the clinical community to better understand the role that PCR can play in the diagnosis of life threatening fungal infections, such as Pneumocystis, as early as possible in at risk patient populations. The results of the trial were published, ahead of print, in the March 2, 2011, Journal of Clinical Microbiology.
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LabMedica
White Cell Count Predicts Kidney Disease Prognosis
he number of lymphocytes in the blood is a possible prognostic indicator for renal cell carcinoma (RCC). The lymphocytes are one of the types of white blood cells that are routinely enumerated in clinical laboratories and the low counts may be indicative of a suppressed immune system. Medical oncologists at the Fox Chase Cancer Center, (Philadelphia, PA, USA; www.fccc.edu), evaluated data from more than 500 patients with the most common form of RCC, called clear cell RCC, who had their kidneys surgically removed at Fox Chase between 1994 and 2009. They found a clear relationship between low lymphocyte counts within three months prior to surgery and a poor prognosis. The scientists found that lower lymphocyte levels were associated with a higher tumor grade, a higher pathologic tumor stage, the presence of distant metastases, and a higher classification of malignant tumors (TNM) stage, which is a combined indicator of tumor stage, spread to regional lymph nodes, and distant metastasis. They also found that low counts were associated with a lower overall survival rate, even when they accounted for patient age, tumor stage, and metastasis. Sunil Saroha, MD medical oncology fellow at Fox Chase and lead author on the study, said, There has been this need for looking at prognostic markers that are available prior to surgical procedures. It would be nice to know before the surgery if the tumor is going to be aggressive and how aggressive we need to be, with the goal of individualizing therapies. This simple test can really help identify patients at the outset who are at risk of very aggressive disease and who may not do well with current therapies. Each year, kidney cancer is diagnosed in nearly 60,000 people in the US Many of these patients undergo surgery to remove the affected kidney, but this procedure can be risky for the elderly and those who have other health problems. Unfortunately, the prognosis of kidney cancer patients often cannot be determined until tumor samples are surgically removed and evaluated. For example, if a young RCC patient does not have a low lymphocyte count, and is otherwise healthy, a doctor may decide not to pursue the more aggressive therapies, such as surgery and chemotherapy. The study will be presented at the Annual Meeting of the American Society of Clinical Oncology on June 5, 2011, in Chicago (IL, USA).
Image: Colored scanning electron micrograph (SEM) of red blood cells (erythrocytes) and a white blood cell (lymphocyte, blue) (Photo courtesy of Steve Gschmeissner / SPL).
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PRODUCT NEWS
PIPETTOR
Globe Scientific
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Helmer
ANTIBODY KIT
Hemagen Diagnostics
CHEMISTRY ANALYZER
Ortho Clinical Diagnostics
The Diamond Advance Pipettor is fully autoclavable and features an adjustable volume. The lightweight pipettor is easy to use and offers an ergonomic design for comfortable handling, a recalibration tool, shelfmounting stand, and a sample pack of pipette tips.
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The i.C3 offers constant temperature monitoring and control on all i.Series refrigerators and freezers. The fullcolor touch screen offers easy-touse icon navigation, and allows multiple information logs with historical data to be downloaded and saved.
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The Virgo Cardiolipin IgG antibody kit is an ELISA designed for the quantitative measurement of circulating IgG autoantibodies to cardiolipin. Two options offer either a 480 determinations kit, or a 96 determinations kit with lyophylied reagents.
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The VITROS 4600 is designed to provide high-quality, reliable test results for mid- to high-volume laboratories. The state-of-the-art analyzer completes the VITROS x600 family of systems, which includes the 5600 integrated and 3600 immunodiagnostic systems.
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Potential Biomarker for Aggressive Breast Carcinoma

possible role of the squamous cell-carcinoma antigen (SCCA) has been discovered in the progression of breast cancer. Molecular and pathology analyses revealed SCCA expression in breast cancer-tissue samples increased when patients had high grade and advanced cancer and the presence of SCCA predicted poor prognosis. Scientists at Stony Brook University School of Medicine, (Stony Brook, NY, USA; www. stonybrookmedicalcenter.org), analyzed the SCCA expression on 1,360 breast tumor tissue samples and 124 samples of normal breast tissue as controls. They used various techniques including immunoblot analysis, tissue microarrays, and immunohistochemistry. Expression of SCCA was observed in only 0.3% of grade 1 tumors, but increased to 2.5% and 9.4% in grades 2 and 3 tumors, respectively. For the various stages of breast cancer in nonmetastatic disease, the progression was similar. Positivity for SCCA was doc-
umented in 2.4% of Stage I cancers, 3.1% of Stage II cancers, and 8.6% of Stage III cancers. Squamous cell carcinoma antigen belongs to the serine protease inhibitor (Serpin) family of proteins and is an inhibitor of cellular proteases that digests other proteins. Elevated expression of SCCA has been used in medicine as a biomarker for aggressive squamous-cell carcinoma in cancers of the cervix, lung, and head and neck. Its expression has also been detected in cancers that are not originated from squamous cells such as liver cancer. The scientists also found that SCCA-expressing cells are specifically sensitive to drugs that induce misfolded proteins. Wei-Xing Zong, PhD, associate professor and a senior author of the study, said, While there has been significant progress in treating breast cancer, aggressive disease remains difficult to treat and cure. Our findings open the door for SCCA to be explored as a useful marker for predicting outcomes of those suffering from aggressive breast
cancers and for SCCA to become a potential therapeutic target to treat cancers unresponsive to current therapies. The study was published online on April 19, 2011, in Public Library of Science ONE (PLoS ONE).
Image: Colored transmission electron micrograph (TEM) of a section through carcinoma cancer cells in a female breast (Photo courtesy of Steve Gschmeissner / SPL).
Gene Expression Model Predicts Pathological Node Status
molecular test has been developed that ascertains which bladder cancer patients may have malignant involvement in their lymph nodes at the time of surgery. A gene expression model (GEM) has been developed that predict the pathological node status in primary tumor tissues. Archival formalin-fixed paraffin embedded (FFPE) tissues can be analyzed by microarray technology to support the model. A multicenter collaborative study was performed at the University of Colorado Cancer Center, (Aurora, CO, USA; www.uch.edu), whereby 20 genes were analyzed on specimens from three independent cohorts of patients who underwent cystectomy and lymphadenectomy for bladder cancer. All patients were clinically node negative before cystectomy and had complete pathological staging infor-
mation. Archival tissues could only be retrieved for 200 of 327 patients reported, of which 185 produced nucleic acid extracts of sufficient quality for microarray analysis. Tissue core were extracted from the FFPE block and these samples were used for nucleic acid extraction, verification, amplification, and hybridization to HG-U133 plus 2.0 arrays (Affymetrix; Santa Clara, CA, USA; www.affymetrix.com), with analysis by robust multichip average (RMA). The investigators broadened the study by identifying ribonucleic acid (RNA) transcripts detected with high fidelity independently of sample preservation, either fresh freezing or FFPE, before development of the GEM. To that end, they used 32 paired fresh frozen and FFPE tissues profiled by microarrays to identify probes which were further refined to ensure they are
expressed in transurethral resection (TUR)-acquired tumors as well as cystectomies. Bladder cancer is the fourth most common cancer diagnosed in males in the USA, who are three times more likely to be diagnosed with the disease than women are. Dan Theodorescu, MD, PhD, urological surgeon, and lead author of the study, said, Randomized clinical trials have shown that giving neoadjuvant chemotherapy extends patient lives, but only 5% to 15% of patients benefit. Patients who have cancer in the lymph nodes at time of diagnosis are likely to benefit the most. We validated the tests ability to predict lymph node spread of the cancer in a large sample of patients from a randomized trial. A clinical trial of using the test as a treatment guide is being planned. The study was published February 2011, in Lancet Oncology.
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LabMedica
Blood Biomarker Associated with Risk of Alzheimers
berrant DNA can be tracked on an individual basis in the blood of patients suffering from primary aggressive brain tumors. Following surgery to remove a tumor, the tissue can be sequenced and the blood taken at the same time can analyzed for the presence of the specific glioblastoma DNA. Scientists at University of Cincinnati, (Cincinnati, OH, USA; www.uc.edu), working with a multidisciplinary team, have begun sequencing individual glioblastoma genomes and tracking abnormalities through the bloodstream. They hope that by mapping the various DNA rearrangements of glioblastoma tumors they will be able to establish biomarkers that will help them track the cancers progress and guide their efforts to treat patients more effectively. They also hope the biomarkers will help them identify targets for new, improved therapies for the future. The sequencing of glioblastoma multiforme (GBM) tumors will be done on the GenomeAnalyzer (Illumina Inc.; San Diego, CA, USA; www.illumina.com), and performed by the department of genetics at Albert Einstein College of Medicine (New York, NY, USA; www.einstein.yu.edu). Equally important, the discovery of biomarkers may provide scientists with new therapeutic targets. By identifying a specific genetic abnormality or mutation, for example, they can work to develop a future therapy that attacks that mutation. Olivier Rixe, MD, PhD, the studys principal investigator, said, There will be some circulating DNA in the blood coming from the tumor, and we will follow those very specific abnormalities. It is very much a personalized study, because we are not talking about the genetic abnormalities of other patients. We are talking about the sequencing of a biopsy of a specific individuals tumor. And we are talking about tracking individualized, personalized abnormalities. Glioblastoma multiforme (GBM) is
the most common and most aggressive type of primary brain tumor in humans, involving glial cells and accounting for 52% of all parenchymal brain tumor cases and 20% of all intracranial tumors. Despite being the most prevalent form of primary brain tumor, GBMs occur in only 2-3 cases per 100,000 people in Europe and North America.
Image: The GenomeAnalyzer, designed for the sequencing of GBM tumors (Photo courtesy of Illumina).
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The Purair 20 features a face velocity at 100 fpm that ensures containment of fumes, and an alarm to alert the operator when the airflow falls to an unacceptable level. Additional benefits include a removable spillage tray, and optional integral lighting.
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The Instant-View tests are designed to aid in the diagnosis of an acute myocardial infarction using whole blood or serum. The one-step tests are over 94.2% specific, can be stored at room temperature, and offer results in 15 minutes.
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The Liqui-Stat offers quality POCT analysis at any medical location or remote area. Key features include prefilled barcoded cuvettes R1 and R2, LCD touch screen, enhanced versatility, compatibility with LIS, integrated printer, and results available in two to five minutes.
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The iWO is designed to meet the requirements of microplate-based immunoassays. Product highlights include 8- and 12-way manifold for 96-well microplates, flexible wash procedure, priming and rinsing, choice of wash liquids, and a magnetic particle washing option.
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Rapid Diagnostic for C. difficile Eliminates Extraction Step
new Clostridium difficile diagnostic test enables processing of up to 94 patient specimens in about an hour. The Simplexa C. difficile universal direct test is performed on liquid or unformed human stool samples, and detects toxin-producing strains of C. difficile, including NAP1/B1/027. The new CE marked in vitro diagnostic (IVD) test enables fast, high volume lab testing, eliminating the traditional extraction step. The C. difficile diagnostic is the first test from the Focus Diagnostics (Cypress CA, USA; www.focusdx.com) Simplexa product line for the hospital-acquired infection (HAI) market. It was unveiled by Focus together with the CE marked Simplexa Epstein Barr (EBV) and BK Virus tests during the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) Tradeshow, which took place May 7-10, 2011, in Milan (Italy). The three Simplexa tests are CE marked and available in Europe. Simplexa tests are run on the 3M Integrated Cycler and employ real-time polymerase chain reaction (RT-PCR) to detect viruses, bacteria, and other agents qualitatively and quantitatively.
C. difficile infection (CDI) is a bacterial infection that generally affects patients over 65 in age, on prolonged use of broad-spectrum antibiotics, and those who have recently undergone gastrointestinal surgery or are immunocompromised. In major European Union (EU) countries, such as Belgium, Denmark, France, Germany, Italy, Netherlands, Spain and the United Kingdom, CDI is estimated to be responsible for 1.1 in 1,000 hospital admissions and is expected to double over the next four decades. Clostridium difficile is a common cause of antibiotic-associated diarrhea and an extremely important and serious hospital-acquired infection, said Jay M. Lieberman, MD, medical director for Quest Diagnostics (Madison, NJ, USA; www.questdiagnostics.com) and Focus Diagnostics. C. difficile infections (CDI) range in severity from mild diarrhea to life-threatening pseudomembranous colitis, and result in significant suffering and
deaths. Timely diagnosis is essential for clinicians when treating patients presenting with possible C. difficile disease. Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics.
Image: Colored scanning electron micrograph (SEM) of dividing C. difficile bacterial cells (yellow) (Photo courtesy of Paul Gunning / SPL).
Genetic-Based Risk Test for Colorectal Cancer Being Developed
he development of a new genetic-based risk assessment test for colorectal cancer with clinical validation is being supported by collaboration between two companies. Bar Harbor BioTechnology (BHB; Trenton, Maine, USA; www.bhbio.com), Inc. and Clinical Reference Laboratory, Inc. (CRL; Lenexa, Kansas, USA; www.crlcorp.com) have announced the collaboration, which involves the continued development of BHBs new geneticbased test for colorectal cancer risk with clinical validation support provided by CRLs CLIA-certified laboratory services. CRL will provide laboratory-testing services in
molecular diagnostics and clinical trials of the new test. The new arrangement will give CRL and BHB the opportunity to combine BHBs bioinformatics and quantitative polymerase chain reaction (qPCR) assay development team with CRLs extensive molecular lab testing experience to create new molecular diagnostic tests. Further details of the tests remain undisclosed but both companies indicate that the agreement envisions future projects and the development of additional tests. CRL is an ideal partner for our company as we continue to develop our risk assessment tests. Their CLIA-certified testing services accelerate our development plans by leveraging on
their expertise and state of the art laboratory; we will get the results we need immediately, said Robert Phelps, CEO of BHB. Bar Harbor BioTechnology manufactures software and consumables for purposes of genetic research in areas of cancer, stem cell research, immunology, metabolism, and specific neurological disorders. The company created a new diagnostic division in 2010. CRL is a privately held reference laboratory offering testing services in the areas of clinical trials, corporate wellness programs, genomics, insurance, molecular diagnostics, bioanalytics, and toxicology.
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LabMedica
Antigen Test Evaluated for Blastomycosis
commercially available assay for detection of Blastomyces dermatitidis antigen has been modified to permit quantitation in subjects with newly diagnosed blastomycosis. An sandwich enzyme immunoassay (EIA) is available that will detect the antigen of the pathogenic mycoses B. dermatitidis in patients serum, urine, cerebral spinal fluid, and other sterile body fluids. In a study carried out at the University of Arkansas for Medical Sciences (Little Rock, AR, USA; www.uams.edu), samples were assayed from patients with newly diagnosed blastomycosis. Specimens from 27 subjects were analyzed and urine specimens from 25 healthy subjects and 25 subjects with conditions other than histoplas-
Blood Transfer Devices Assessed for Malaria Test

comparison has been made of different devices for transferring blood to the rapid diagnostic test (RDT) for malaria in three developing countries. The five blood transfer devices evaluated were the loop and inverted cup, made of hard plastic; a strawpipette and calibrated pipette, made of soft plastic, and a glass capillary tube. A study was conducted between August and November 2009 among 227 health workers in Nigeria, the Philippines, and Uganda, under the auspices of the Foundation for Innovative New Diagnostics, (FIND; Geneva, Switzerland; www. finddiagnostics.org). The participants were recruited from the staff of frontline health centers and community-based malaria programs. The devices were evaluated for accuracy, safety, and ease of use. The participating health workers used each device to transfer blood from a simulated finger prick site to filter paper. Blood volume transferred was calculated from the area of blood spots deposited on filter paper. The overall mean volumes transferred by devices differed significantly from the target volume of 5 L which is the minimum amount recommended for the most RDTs. The new inverted cup device transferred a mean of 4.6 L, which most closely approximated the target volume. The glass capillary was excluded from volume analysis, as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures to 10% of the health worker. Blood exposures for the other four devices ranged from 2% to 6%. According to 91% of the health workers, the inverted cup was considered easiest to use in blood collection, while the straw-pipette and calibrated pipette were rated the most difficult to use. Rapid diagnostic tests are becoming the standard method of detection of malaria in poor resource settings. The blood transfer device is an essential part of the kit because the sensitivity of the tests is compromised when an inadequate volume is transferred to the RDT cassette, especially when parasite density falls below 200 parasite/L. The findings of this study have relevance for any point-of-care diagnostics that require blood sampling. The variability in device performance demonstrated the need to devote attention to this issue when implementing RDT-based diagnostic programs. The study was published online on February 8, 2011, in the Malaria Journal.
mosis or blastomycosis were analyzed to provide negative controls. If no antigen was detectable, the urine specimen was concentrated 10-fold and reanalyzed. Serum specimens were tested before and after treatment with ethylenediaminetetraacetic acid (EDTA) to dissociate immune complexes. Treatment of specimens with EDTA has not been shown to cause false-positive results in another fungal assay. The assay used was the Mvista Blastomyces dermatitidis Antigen EIA, (MiraVista Diagnostics, Indianapolis, IN, USA; www.miravistalabs.com). Of 27 patients, 23 (85.1%) had detectable B. dermatitidis antigen detected in their urine samples with a median of a 1.49 ng/mL, with a range of 0.21 ng/mL - 16.90 ng/mL. In two of these 23, positive results were obtained only after concentration of the urine specimen. Nine of 11 (81.8%) subjects had detectable B. dermatitidis antigen in their serum, including three subjects with negative
results before treatment of serum with EDTA and positive results after EDTA treatment. B. dermatitidis antigen was not detected in specimens from 50 control subjects, but was detected in 15 patients with histoplasmosis. The authors concluded that the B. dermatitidis antigen was detected in most of the patients with blastomycosis and that it can be a useful tool for timely diagnosis. The study was published in February 2011, in the journal Diagnostic Microbiology and Infectious Disease. Blastomycosis is an infection caused by inhaling microscopic spores produced by the fungus B. dermatitidis. Blastomycosis may be limited to the lungs or also involve the skin and bones. In its most severe form, the infection can spread throughout the body and become systemic. The fungus that causes the disease is found in moist soil and wood in the southeastern US, the Mississippi River valley, southern Canada, and Central America.
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PRODUCT NEWS
BENCHTOP CENTRIFUGE
Beckman Coulter
STRIP PLATES
BRAND
HISTOLOGY CASSETTE LABEL

Computype
PCR DETECTION KITS

Daan Diagnostics
The Allegra X-30 is a compact instrument designed to provide high-level performance in a wide range of applications. The X-30 is available individually, or packaged with the appropriate rotors and labware, and is intended for general research use and clinical sample preparation.
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The BRANDplates 96-well strip plates 12x8 feature ideal optical characteristics, and offer high flexibility in allowing the user to decide on the number of cavities to be filled. The strip plates are available with or without grid in versions with highbinding or medium-binding capacity.
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The TS968 is a high-performance, resilient label that is resistant to harsh chemicals and extreme temperatures. It requires no additional label attachment equipment, conserves lab space, and is intended to save time and trouble in the lab.
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The latest real-time PCR pathogen detection kits are easy to use, and offer sensitive primers and accurate detection. The efficient kits are also compatible with most PCR instruments, and allow for timesaving set ups and cycling conditions.
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Specimen Processing System Utilizes Robotic Plate Management

barcode driven, conveyor-connected specimen-processing system utilizes robotic plate management to automate workflow in Microbiology. The system, which can manage many different aspects of specimen processing and workup, is called WASPLab. It can handle planting and streaking, Gram slide preparation, enrichment broth inoculation, robotic incubation and storage, plate image analysis, identification and antimicrobial susceptibility testing (AST/ID) inoculum preparation, Kirby-Bauer disk application, and even Maldi-Tof target plate seeding. Copan Diagnostics (Murrieta, CA, USA; www. copanusa.com) unveiled the system in Milan (Italy) during the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) General Meeting from May 7 to May 10, 2011, and plans to display the system in New
Orleans (LA, USA) during the American Society for Microbiology (ASM) 111th General Meeting from May 21 to May 24, 2011. We have developed WASPLab with the future of Microbiology in mind and an ongoing commitment to provide a solution for an automated single-piece flow system for specimen processing, said Norman Sharples, Copan Diagnostics executive VP. Copan is a manufacturer of collection and transport systems and is well known in the field of preanalytics. The company offers a complete line of automation and a range of microbial sampling products used for traditional culture analysis and molecular diagnostic assays. It supplies bacteriology swabs (flocked
swabs and eSwabs), viral transport media (VTM), and molecular systems.
Image: The WASP walkaway specimen processor (Photo courtesy of Copan Diagnostics).
Three Supplementary Genes Linked to Breast Cancer
newly discovered association has been found between three genes and the most common form of breast cancer. The genes were found directly next to the estrogen receptor gene, the main driver of hormonal breast cancer. The estrogen receptor has been intensively studied by scientists for decades and is located in one of the intensively studied areas of the genome. Scientists at The Institute of Cancer Research, (ICR; London, UK; www.icr.ac.uk), studied 104 patients with hormonal, also known as estrogen receptor (ER) positive, breast cancer. They wanted to find the genes that were most closely linked to the estrogen receptor. The three genes identified were: chromosome 6 open reading frame 96 (C6ORF96), C6ORF97, and C6ORF211. All three were found to be linked to the estrogen receptor, but working separately from it. As a result, their activity is unlikely to be affected by current treatments, such as tamoxifen, which target the estro-
gen receptor. This could mean that they are potential targets for new drug treatments. The human gene C6ORF211 was shown to drive the growth of tumors and the team sees this as the most likely target for new treatments. The gene C6ORF97 was shown to be an indicator of a tumor not relapsing, and also a good predictor of response to tamoxifen. Less is known about the gene C6ORF96, but it is being investigated by the team. Mitchell Dowsett, PhD, professor of biochemical endocrinology at the ICR, said, This investigation is exciting because it shows that while the estrogen receptor is the main driver of hormonal breast cancer, there are others next door to it that also appear to influence breast cancer behavior. We now need to better understand how they work together and how we can utilize them to save lives of women with breast cancer. In Britain, nearly 48,000 women and around 300 men are diagnosed every year with breast cancer; the most diagnosed commonly cancer in the UK.
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LabMedica
Malaria Test Assessed in Nonendemic Setting
rapid diagnostic test (RDT) for malaria has been evaluated in a standard reference laboratory using stored and fresh blood samples. In nonendemic settings, where microscopic expertise is lacking due to low incidence, malaria RDTs are of value for the diagnosis of malaria and they provide information about the possibly fatal Plasmodium falciparum infections. Scientists at Maastricht University, (Maastricht, The Netherlands; www.maastrichtuniversity.nl), performed both a retrospective study on 341 stored blood samples and prospective study. In the prospective study, the SD Bioline Malaria Ag 05FK40, (SDFK40), RDT was used on 181 fresh samples and run side by side with two other RDTs, OptiMAL and SDFK60. The SDFK40 is a lateral flow antigen-detection test in a cassette format, targeting P. falciparum-specific parasite lactate dehydrogenase (Pf-pLDH) and pan-Plasmodium LDH, (pan-pLDH). The prospective part was performed between March 2009 and October 2010, and included first samples of each patient for which microscopy or one of the both routinely used RDTs (OptiMAL and SDFK60) were positive for malaria. Overall sensitivities for P. falciparum tested retrospectively and prospectively were 67.9% and 78.8%, reaching 100% and 94.6% at parasite densities greater than 1,000/L. Sensitivity at parasite densities less than 100/L was 9.1%. Overall sensitivities for P. vivax and P. ovale were 86.7% and
80.0% (retrospectively) and 92.9% and 76.9% (prospectively), reaching 94.7% for both species (retrospective panel) at parasite densities greater than 500/L. Sensitivity for P. malariae was 21.4%. None of the Plasmodium negative samples in the retrospective panel reacted positive. The authors concluded that SDFK40 RDT (Standard Diagnostics Inc.; Suwon, Korea; www.standardia.com), performed exceptionally for P. falciparum samples at high parasite densities as well as for detection of P. vivax and P. ovale at parasite densities greater than 500/L. The SDFK40 was evaluated as easy to use, with an excellent clearance of the background and clearly visible test lines. Compared to OptiMAL Rapid Malaria test, (Diamed AG; Cressier, Switzerland; www. diamed.com), and Standard Diagnostics other RDT, called SD Bioline Ag Pf/Pan 05FK60 (SDFK60), SDFK40 showed lower sensitivities for P. falci-
parum, but better detection of P. ovale. The study was published online on January 12, 2011, in the Malaria Journal.
Image: Colored scanning electron micrograph (SEM) of a freeze-fractured red blood cell (erythrocyte, green) infected with a Plasmodium falciparum protozoan (orange and blue) (Photo courtesy of the NIBSC).
Circulating Microvesicle Based Assay Is Potential Prostate Cancer Diagnostic

circulating microvesicle (cMV)-based test is a potentially powerful diagnostic tool for detecting prostate cancer. cMVs are sub-cellular membrane-bound vesicles, ranging from 30 nm to 1,500 nm in size, that are found circulating in the blood and other body fluids. They are released from various cell types under both normal and pathologic conditions, including cancer. Each population of cMV expresses an array of proteins which reflects its cell-of-origin. Carisome Technology is a versatile blood-based, highly reproducible testing technology. The technology platform identifies and characterizes cMVs, creating disease-specific, cMV-based biosignatures, which can be made up of a combination of biomarkers. The unique cMV biosignature can then be used for the diagnosis, prognosis, and measurement of therapeutic response. The assay that enables the isolation, capture, and characterization of cMVs specific to prostate cancer was developed by Caris Life Sciences (Dallas, TX, USA; www.carislifesciences.com). It has potential to deliver more accurate diagnoses for men with prostate cancer than current methods. A poster highlighting the potential of the circulating microvesicle (cMV)-based prostate cancer test was presented at the American Urological Association (AUA) 2011 Annual Meeting (www. aua2011.org), which was held in Washington DC (USA) from May 14-19, 2011.
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LabMedica
Urine-Based Diagnostics Tool Detects Tuberculosis
n optical biosensor diagnostics device detects tuberculosis in urine samples in 1520 min. The waveguide-based system is capable of providing a qualitative tuberculosis diagnosis in a very short time using only a few drops of human urine. This is a significant breakthrough compared to sputum, blood, and skin tests that often take several days or weeks for results. Recently developed polymerase chain reaction (PCR)-based diagnostics, which take approximately two hours to produce results, are significantly more expensive. Biomagnetics Diagnostics Corporation (Orangevale, CA, USA; www.biomagneticsbmgp.com) is currently developing the waveguide-based advanced integrated optical biosensor through its cooperative research and development agreement
with Los Alamos National Security, LLC (Santa Fe, NM, USA; www.lansllc.com). The biosensor will initially be used for cholera, tuberculosis, and malaria diagnosis. The optical biosensor was introduced in a video that can be viewed at www.youtube.com/ watch?v=pIkGKlm-KZg. Clayton Hardman, CEO of Biomagnetics Diagnostics commented, While the current cost profile is already significantly lower than other tests, we are already working on a new waveguide design that will likely allow us to reduce the cost per test even further. The unit shown in this video is a desktop unit; however, the products for ultimate delivery to the market will also include a handheld device that can be operated by relatively untrained medical personnel at the point of
patient care. We see nothing on the market today, or on the immediate horizon, that can compare to the capabilities of this technology.
Image: The KeyPath MRSA/MSSA blood culture test (Photo courtesy of MicroPhage).
GA Assay Better for Monitoring Diabetic Kidney Patients
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he glycated albumin (GA) assay appears to be far more effective than the hemoglobin A1c (HbA1c) for managing patients with diabetes and advanced kidney failure. A study evaluated 444 patients with diabetes undergoing dialysis. Patients continued their normal treatment and HbA1c monitoring, but also agreed to have a GA test every three months for an average of more than 2.3 years. Barry I. Freedman, MD, John H. Felts III Professor at the Wake Forest Baptist Medical Center (Winston-Salem, NC, USA; www.wakehealth.edu) and colleagues compared the patients HbA1c and GA test results, assessing their ability to predict hospitalizations and survival. They found that the HbA1c failed to predict medical outcomes. In contrast, the GA was a strong predictor of patient survival and hospitalizations. The GA test, developed by Asahi Kasei Pharma Corp. (Tokyo, Japan; www.asahi-kasei.co.jp), measures blood sugars over the past 17 days, as opposed to the longer time frame for HbA1c. In situations where rapid changes occur in blood sugar, the GA gives a more accurate picture of diabetes control. The GA test used in this study is available in Japan, China, and South Korea, but is not yet approved by the US Food and Drug Administration (FDA; Silver Spring, MD, USA; www.fda.gov). The gold standard long-term glucose-monitoring test for patients with diabetes is the HbA1c test. It measures an individuals average blood sugar level over the prior three months. It is the most commonly used long-term blood sugar test, and is widely trusted in the medical community. However, HbA1c results are only accurate when red cells have a normal lifespan. Dialysis patients have shorter red cell survival reducing the time that sugar in the bloodstream has to interact with hemoglobin, and causing lower HbA1c values. The study appeared online in the May 19, 2011 edition of Clinical Journal of the American Society of Nephrology.
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LabMedica
Diagnostic Test Distinguishes Between Active and Latent Tuberculosis
n innovative blood test has been developed as an additional test to distinguish rapidly individuals with active tuberculosis (TB), and from these, those with latent TB infection. By simply performing an extra blood test using a protein of the bacillus, Mycobacterium tuberculosis, named heparin-binding hemagglutinin adhesin (HBHA), it was possible to distinguish between those infected from those who have progressed to the pathological phase of the disease. Scientists at the Catholic University of the Sacred Heart (Rome, Italy; www.unicatt.it) developed the test in collaboration with others at the L. Spallanzani National Institute for Infectious Diseases (INMI; Rome, Italy; www.inmi.it). The team assayed the blood of 87 individuals at different stages of TB who scored positive with the QuantiFERON TB Gold In-Tube test (QFT-IT;
Cellestis GmbH; Darmstadt, Germany; www. cellestis.com). The QFT-IT blood test is an interferon- release assays (IGRA), based on the release of interferon- in response to M. tuberculosis-specific antigens, and is able to identify selectively those who have contracted TB infection. In the study, the scientists developed an innovative diagnostic algorithm, which consists of a response to the protein HBHA in combination with the IGRA and the results have shown that the response to HBHA is associated with latent TB infection. This procedure allows the rapid identification those who really need the treatment for active TB. They showed that the lymphocyte Tcell response to a recombinant and methylated HBHA of M. tuberculosis produced in M. smegmatis a nonpathogenic microorganism is useful to discriminate between active and nonactive
TB disease among those responsive to QFT-IT in a whole blood system. The study was published online on March 29, 2011, in the Public Library of Science journal PLoS ONE.
Image: Colored scanning electron micrograph (SEM) of a macrophage white blood cell (red) engulfing a Mycobacterium tuberculosis bacterium (green) (Photo courtesy of Science Photo Library).
ST2 Levels in Blood Predict Outcomes for Cardiac Patients
patients ST2 level helps physicians make a prognosis for cardiac patients. The ST2 level indicates change in cardiac status and development of cardiovascular complications such as heart failure, at critical clinical decision points, such as initial presentation with chest pain, after recovery from myocardial infarction, and in the cardiac intensive care unit. The Presage ST2 assay was developed by Critical Diagnostics (www.criticaldiagnostics.com). It identifies patients at increased risk of morbidity and mortality from heart disease and helps physicians optimize patient care.
The protein cardiac biomarker was highlighted in three presentations at the American College of Cardiology (ACC) meeting held in New Orleans from April 2-5, 2011. In a poster presentation, J. Zilinski et al. demonstrated in a study of 30 patients that measurement of ST2 can assist in care decisions in advanced stage heart failure patients. A second poster presented by S. Aldous et al. showed that levels of ST2 predicted heart failure and all cause mortality in patients presenting to the emergency department with chest pain. In the third poster presented by M. C. Kontos et al., the scientists showed that increased ST2 and
brain naturietic peptide (BNP) levels identified post myocardial infarction (MI) patients who had clinical and echocardiograph variables associated with worse prognoses. Referring to the posters displayed at the ACC meeting James Snider, president of Critical Diagnostics said, The studies presented here show that ST2 can be a valuable tool for clinicians across the spectrum of heart failure: from predicting onset to predicting outcomes in late-stage patients. These clinical data continue to build evidence that ST2 may help aid physicians in clinical decision-making.
Blood Glucose Measurements Can Be Made From Tears
new sensor would enable people to draw tear fluid from their eyes to get a glucose-level test sample. Glucose in tear fluid may give an indication of glucose levels in the blood as accurately as a test using a blood sample. The technology was designed by bioengineer Jeffrey T. LaBelle, a professor in the School of Biological and Health Systems Engineering, one of the Arizona State University (Tempe, AZ, USA; http://asunews.asu.edu) Ira A. Fulton Schools of Engineering. Prof. LaBelle is leading the ASU-Mayo team
along with Mayo Clinic (Scottsdale, AZ, USA; www.mayoclinic.org/arizona) physicians Curtiss B. Cook, MD, an endocrinologist, and Dharmendra (Dave) Patel, MD, chair of Mayos Department of Surgical Ophthalmology. Many people with diabetes suffer due to the difficulty of managing their blood glucose levels. It is recommended that they monitor their own glucose levels, but current monitoring devices typically require patients to perform the painful task of pricking their finger to draw blood for a test sample and many
patients must do it several times each day. The major challenges are performing the test quickly, efficiently, with reproducible results, without letting the test sample evaporate and without stimulating a stress response that causes people to rub their eyes intensely, Prof. LaBelle said. Because of its potential impact on health care, the technology has drawn interest from BioAccel (Phoenix, AZ, USA; www.bioaccel.org), an Arizona nonprofit that works to accelerate efforts to bring biomedical technologies to the marketplace.
Early-Onset Sepsis Rates in Newborns Determined
urrent early-onset sepsis rates among newborns, the pathogens involved, and associated morbidity and mortality were determined in the United States. The multisite national study demonstrated that the most frequent pathogens associated with sepsis were group B streptococci (GBS) in full-term infants and Escherichia coli in preterm infants. Nearly 400,000 newborns were included in the study, which also found that infection rates increased with decreasing gestational age and birth weight. The overall rate of infection was 0.98 per 1,000 live births; 0.41 per 1,000 live births involving GBS and 0.28 per 1,000 live births involving E. coli. Bloodstream infections in newborns can lead to serious complications with substantial morbidity
and mortality. The pathogens responsible for neonatal infections have changed over time. In recent years, however, antibiotic prophylaxis given to atrisk mothers has reduced the incidence of earlyonset group B streptococcal infections among their babies. Infections occur in almost one case per thousand live births, said Barbara Stoll, MD, lead investigator for the study. Prof. Stoll is the George W. Brumley, Jr., professor and chair, Department of Pediatrics in Emory University School of Medicine (Atlanta, GA, USA; www.med.emory.edu). With approximately 4 million births a year in the United States, this equates to a substantial burden of disease. We estimate that approximately 3,000 infants
a year develop early-onset sepsis. With current mortality rates, approximately 300 to 350 deaths per year are associated with neonatal sepsis. So, its not inconsequential. The study also shows that opportunities for prevention of neonatal GBS infections continue to be missed. Missed opportunities for prevention of GBS include failure to screen all women who deliver at term, failure to provide antibiotics to all colonized women or to those who delivered preterm with unknown colonization status, and false negative GBS screens among women who deliver with GBS infection, added Prof. Stoll. The study appeared online on April 25, 2011 and in the May 2011 issue of Pediatrics.
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PRODUCT NEWS
RVP FAST TEST

Luminex
DNA EXTRACTION KIT

Phthisis Diagnostics
PCR TEST
QIAGEN
BIOCHEMISTRY ASSAY
Randox Laboratories
The xTGA respiratory viral panel fast test delivers 96 actionable patient results within just a few hours. The test is intended to help labs and healthcare providers improve efficiency in the lab, while making it easier for physicians to identify and act on a course of treatment.
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The E-Sphere stool DNA extraction kit allows manual DNA extraction from 12 stool samples in less than 30 minutes. The streamlined process includes just nine steps, and minimizes sample contamination risk with only two sample transfers.
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The Multiplex PCR Plus Kit allows researchers to amplify several targets in one PCR run. The kit provides fast reaction times and comes with a preoptimized protocol, delivering reliable results on the first attempt.
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The latest quantitative, automated assay is a highly sensitive and specific biomarker for myocardial ischemia. The assay is designed for H-FABP, to be used in the diagnosis and management of patients with suspected acute coronary syndrome.
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RNAs Altered in Melanoma

long, noncoding (lnc) RNA is elevated in melanoma cells, where it promotes cellular survival and invasion. Scientists have discovered that levels of a relatively understudied group of RNAslong, noncoding RNAs (lncRNAs)are altered in human melanoma. Dr. Ranjan Perera, associate professor at Sanford-Burnham Medical Research Institute (Sanford-Burnham; Orlando, FL, USA; www. sanfordburnham.org), and collaborators at the University of Queensland (Brisbane, Australia; www.uq.edu.au) compared lncRNAs in several laboratory cell-lines of melanoma and normal skin cells, as well as in 30 different human patient samples. They found that levels of the lncRNA, SPRY4-IT1, were particularly high in melanoma cells, but not in normal skin cells. The study, published online May 10, 2011, in the journal Cancer Research showed that the elevated levels of SPRY4-IT1 in melanoma cells, promoted cellular survival and invasion. To further probe the function of this lncRNA, they looked at what happens in a melanoma cellline where SPRY4-IT1 levels are significantly
reduced. Cellular growth was impaired and cell death was increased in the SPRY4-IT1-deficient melanoma cells, as compared to melanoma cells with fully functioning lncRNAs. In addition, the ability of melanoma cells to invade the extracellular matrix (an early step in cancer cell metastasis) was reduced in cells lacking SPRY4-IT1. The elevated expression of SPRY4-IT1 in melanoma cells, its accumulation in the cell cytoplasm, and effects on cell dynamics all suggest that increased SPRY4-IT1 may play an important role in the molecular underpinnings of human melanoma, said Prof. Perera. Based on this information, we believe SPRY4-IT1 could be an early biomarker for the detection of melanoma. In a separate study published in the journal PLoS ONE, in November 2010, Dr. Pereras group reported that melanoma cells have lower levels of
a different noncoding RNA, called miR-211. Together, these two studies give scientists a better understanding of melanoma development, which in turn will help them design new diagnostics and therapeutics for this often-fatal disease.
Image: Colored scanning electron micrograph (SEM) of a melanoma cancer cell (Photo courtesy of Steve Gschmeissner / SPL).
Velocity of PSA Test Indicates Prognosis
levated levels of the prostate-specific antigen (PSA) blood test is indicative of prostate cancer, but can also be caused by prostate inflammation or enlargement or other conditions. The PSA test is used to screen patients at risk for prostate cancer, but even after a negative biopsy, if the PSA levels increase with time, a manifestation of the disease is the mostly likely consequence. Urologists at Northwestern Memorial Hospital, (Chicago, IL, USA; www.nmh.org), looked in their database at the history of 1,358 patients who underwent prostate biopsy after previous screening with three PSA tests between 2003 and 2010. There were 106 who had a PSA velocity score of 0.35 ng/mL/year and a negative biopsy. From these, of the 97 patients with a rising PSA trend or
velocity, who had a subsequent negative biopsy, they found that 66% of patients were eventually diagnosed with prostate cancer, 20% had a benign prostate, 8% had prostatitis and 6% had premalignant lesions. False-negative tests can often be explained by low volume or high Gleason grade disease, prior resolved prostatitis, or possible PSA assay standardization bias. William Catalona, MD, director of the clinical prostate cancer program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University said, Our findings show an elevated and rising PSA level or velocity should lead a clinician to follow a patient more closely, even if he has a negative biopsy. One negative biopsy isnt the end of the road. Prof. Catalona, known as the father of
the PSA screening, was the first to show in 1991 that a simple blood test measuring PSA levels could be used to detect prostate cancer. The PSA test has come under fire as a screening test because it sometimes prompts biopsies that turn out to be normal. Gregory Auffenberg, MD, a resident in urology at the Feinberg School, commented, This underscores the importance of using a patients individual PSA trend when deciding whether to pursue a prostate biopsy. It is not enough to only look at an individual PSA value when historical data is also available. The results of the study were presented on May 18, 2011, at the American Urological Association Annual Meeting (www.aua2011.org) held in Atlanta (GA, USA.
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LabMedica
Molecular Tests Detect Epstein-Barr and BK Viruses

olecular tests aid in detecting infectious disease viruses for organ transplant and other immunocompromised patients. Two new Simplexa-branded molecular test kits enable hospital labs to perform advanced molecular testing for Epstein-Barr (EBV) and BK viruses. They are the first products from the Simplexa line to aid in the clinical management of patients with compromised immunity. Simplexa tests, running on the 3M Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) diagnostic technologies to detect viruses, bacteria, and other agents qualitatively and quantitatively. The EBV test is performed on whole blood specimens and the BK virus test is performed on either urine or plasma specimens to quantitatively detect the viruses. Most healthy people are infected with EBV, the cause of mononucleosis, and BK polyomavirus at some point during their lives. After the primary infection, the viruses typically become latent in the body. However, the viruses can reactivate when the immune system is significantly weakened, for example after organ transplantation, and cause fever, organ rejection, and even death. Quest Diagnostics Inc., (Madison, NJ, USA; www.QuestDiagnostics.com) a provider of diagnostic testing, information, and services, announced that the two new Simplexa-branded molecular test kits developed by its Focus Diagnostics (Cypress, CA, USA; www. focusdiagnostics.com) business have been CE marked for distribution to approximately 35 countries in Europe. The success of solid organ transplantation can hinge on how well a physician detects and prevents complications from infectious diseases like EBV and BK, said John G Hurrell, PhD, vice president and general manager, Focus Diagnostics. CE marking of our new Simplexa EBV and BK virus
tests will enable hospital and other labs in Europe to generate reliable results quickly in their own labs, an important advantage for managing these patients. In April 2011, the Simplexa/3M technology won a 2011 Edison Award for new science and medical diagnostic product, based on criteria that included technological innovation and marketplace success.
Image: Colored transmission electron micrograph (TEM) of BK virus particles (Photo courtesy of Dr. Linda Stannard, UCT).
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PRODUCT NEWS
HEMOSTASIS ANALYZER
Tem Systems
TISSUE PROCESSOR
Thermo Fisher Scientific
IMMUNOASSAY ANALYZER
Tosoh Bioscience
IHC/ISH SYSTEM
Ventana Medical Systems
The ROTEM delta analyzer provides in-depth information on all stages of hemostasis. The information about the coagulation process is intended to assist surgical teams with decisions about transfusion, and which products to transfuse to the patient.
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The STP 420ES dual-chamber design allows for processing of STAT samples, as well as special or difficult tissues, without interrupting routine workflow or requiring the use of a second instrument. The unit is designed for same-day diagnosis and streamlined workflows.
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The AIA-360 automated analyzer features a compact size, and a full test menu of ST assays. The analyzer fits in multiple lab environments, and offers STAT assay results in less than 20 minutes, as well as a throughput of 36 results per hour.
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The BenchMark ULTRA with Ultimate Reagent Access allows labs to process IHC and ISH samples as soon as they arrive in the lab. The flexible system also allows lab technicians the ability to add and remove slides and reagents at any time throughout the day.
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Blood Bank Refrigerators, Incubators and Freezers to Be Certified as Medical Devices
lood bank refrigerators, plasma and ultra-low temperature freezers, or CO2 incubators to preserve or cultivate cells, tissues, and blood components for human use will be certified as medical devices. Products include the MCO-19AIC CO2, an incubator with rapid hydrogen peroxide vapor decontamination option, the MBR-305GR blood bank refrigerator, and the MDF-U74V ultra-low temperature freezer. Two new ultralow freezer models will also gain certification: MDF-U55V, the latest V.I.P. freezer, and MDFU700VX, which offers an innovative dual-cooling system for the highest level of sample security. Designed and manufactured by Sanyo Electric
Co Ltd. (Osaka, Japan; http://biomedical. sanyo.com), these instruments preserve or cultivate cells, tissues, and blood components for human use. The company was awarded certification to manufacture blood bank refrigerators, freezers, and incubators as Class IIa Medical Devices by TV-Sd (www.tuev-sued.de), an international certification agency, in 2010. Sanyo is one of the first major international companies to gain Medical Device certification to European Council directives 93/42/EEC and 2007/47/EC across a wide range of refrigeration and incubation products.
Image: The MCO-19AIC CO2 incubator (Photo courtesy of Sanyo Electric).
BRAF Mutation Discovered in Hairy-Cell Leukemia
he BRAF V600E mutation was present in all patients with hairy-cell leukemia (HCL) who were evaluated. This finding has implications for the diagnosis, pathogenesis, and targeted therapy of HCL. Scientists looked for HCL-associated mutations by performing massively parallel sequencing of the whole exome of leukemic and matched normal cells purified from the peripheral blood of an index patient with HCL. Findings were validated by Sanger sequencing in 47 additional patients with HCL. Hairy-cell leukemia (HCL) is a well-defined clinicopathological entity whose underlying genetic lesion is still obscure. The single mutation occurred in every patient in a cohort with hairy cell leukemia, suggesting that targeting the mutation could have major implications for treating the disease, Italian investigators reported. Gene-expression profiling and genome-wide single-nucleotide polymorphism genotyping
failed to pinpoint any recurrent genetic alterations in HCL. Brunangelo Falini, MD, Enrico Tiacci, MD, and colleagues of the University of Perugia (Italy; www.unipg.it) using the more powerful approach to examining the genetic basis of cancer: genomewide massively parallel sequencing of tumor and normal cells from the same patient. They sought to identify recurrent somatic mutations in protein-coding genes, with the goal of gaining more insight into the origin of the disease and identifying new options for diagnosis and treatment. A consequence of this discovery may be that specific drugs/molecules can be developed that inhibit the activated, mutated BRAF gene, thereby preventing continuous stimulation of leukemic cells to divide. The first laboratory results employing these specific inhibitors show promising results. Hairy cell leukemia is characterized by the piling up of leukemic cells in the bone marrow with a lack
of production of normal blood cells, which might be life-threatening, as well as a large spleen, which may lead to significant complaints to the patients involved. The BRAF V600E mutant is a potential therapeutic target in patients with hairy cell leukemia who do not have a response (or have a suboptimal response) to initial therapy with purine analogs, as well as in patients with repeated relapses or unacceptable toxic effects, Dr. Falini and coauthors wrote in conclusion. Notably, BRAF V600E inhibitors have shown remarkable activity in patients with BRAF-mutated metastatic melanoma. These results, along with our in vitro finding that a specific active BRAF inhibitor causes MEK and ERK dephosphorylation in primary hairy cell leukemia cells, warrant the clinical testing of active BRAF inhibitors. The findings were published online in the New England Journal of Medicine (NEJM) on June 11, 2011.
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ELISA ANALYZER
Institut Virion\Serion
ELECTROLYTE ANALYZER
Wiener Lab Group
DRUG PANEL CUP

Wondfo
URINALYSIS REAGENT STRIPS

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The Immunomat is a four-plate benchtop automat with an integrated pipetting system, plate transporter, ELISA washer and reader. The features of the fully automated analyzer ensure an efficient workflow, and allow the processing of up to seven microtitre plates.
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New Facilities Support Clinical Testing Services for Bartonella

new laboratory will support expansion of clinical testing services for hard-to-detect bacteria such as Bartonella. The most effective means of detecting active infection of Bartonella spp. involves the combination of enrichment culture in Bartonella alpha-Proteobacteria growth medium (BAPGM) followed by polymerase chain reaction (PCR) amplification and DNA sequence identification and detection of organism-specific DNA sequences. Galaxy Diagnostics (Research Triangle Park, NC, USA; www. galaxydx.com) EnrichmentPCR improves accuracy of Bartonella detection by more than a factor of 4 over other available techniques. Bartonella
is extremely difficult to detect; conventional tests suffer a high degree of false negatives, leading to missed diagnosis and treatment. The new laboratory facility was opened by Galaxy Diagnostics, which is seeking approval under the Clinical Laboratory Improvement Act (CLIA), a necessary step in performing tests on human blood samples. Our new facilities will enable us to meet the growing demand for our EnrichmentPCR test for Bartonella. People are becoming increasingly aware of the dangers posed by [these] bacteria through news reports, emerging papers, and articles, said Galaxy president Amanda Elam, PhD. The key agent in cat scratch disease (CSD), Bartonella henselae is
increasingly implicated in a wide range of chronic patient conditions affecting the central nervous system, joints, and vascular system. Transmission of the bacteria from host animals to humans is thought to occur most often by flea/tick
bites and by animal bites and scratches.

Image: Bartonella henselae bacilli in cardiac valve of a patient with blood culture-negative endocarditis. The bacilli appear as black granulations (Photo courtesy of Warthin Starry / CDC).
Screening Test Recommended for Heritable Blood Disorder

blood test has been recommended for screening newborns or infants for all forms of an inherited blood disorders as this may reduce morbidity. The hemoglobinopathy is known as Hemoglobin H disease or Alpha Thalassemia and is diagnosed by a variety of tests including high performance liquid chromatography (HPLC). Samples containing more than 25% hemoglobin Barts should be selected for confirmatory testing. Over a 15-year period, scientists at the Childrens Hospital Oakland, (CA, USA; www. childrenshospitaloakland.org), observed and tested 86 patients, of whom 23 had hemoglobin H Constant Spring mutation (HCS). Diagnosis was confirmed by thin-layer isoelectric focusing, and specific -globin gene deletions or mutations were identified by multiplexed gap-polymerase-chainreaction assay. Patients with hemoglobin H have
moderately severe anemia because of gene defects leading to insufficient production of hemoglobin. The disorder does not usually cause significant health problems, except in cases of HCS, a severe form of the disease, which often results in lifethreatening anemia. The study provided a previously undocumented natural history of the disease in young children. The patients with HbH exhibited relatively normal growth and development without needing blood transfusions, but patients with HCS were at highrisk for life-threatening anemia even during infancy. There were significant differences in hemoglobin levels between the HbH group and the HCS group and the absolute reticulocyte count and bilirubin level were consistently higher in patients with HCS. A diagnosis of HCS avoids expending precious
time, which could save a young life and money trying to diagnose the problem. The study also demonstrated that hemoglobin H is not restricted to the traditional Asian ethnic populations. Although 81% patients studied had an Asian background, 5% were Hispanic, 3% were African-American, and 10% had mixed ancestry. The study shows that the advanced DNA testing at Childrens Hospital Oakland can predict the course of the disease during childhood, which helps to ensure proper treatment for all patients. Hemoglobin H disease arises from the deletion of three of four -globin genes and HCS is caused by the deletion of two -globin genes and the Constant Spring mutation. In California, one in 10,000 newborns is diagnosed with hemoglobin H disease. The study was published on February 24, 2011, in the New England Journal of Medicine (NEJM).
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LabMedica
Hypertonic Culture Medium Differentiates Fungal Species
hypertonic glucose agar has been used for phenotypic characterization of two Candida species following molecular classification. Isolates of Candida dubliniensis and C. albicans were distinguished as species by growing them on hypertonic Sabouraud glucose agar (SGA) with 6.5% sodium chloride. Scientists at the University of Delhi (Delhi, India; www.du.ac.in) tested the SGA method on 84 isolates of C. albicans, 18 of C. dubliniensis, and 2 reference strains. Of the test C. albicans isolates, 41 originated from the oropharynx of 27 human immunodeficiency virus (HIV) positive patients and the rest from 41 patients with lung diseases.
Identity of the test fungi was based on their typical phenotypic characteristics and confirmed by a diagnostic polymerase chain reaction (PCR), that targets the novel C. dubliniensis group I intron in the large ribosomal subunit. All of the 84 test and 2 reference C. albicans isolates grew on hypertonic SGA, while, in strong contrast, none of the test and reference C. dubliniensis isolates exhibited any growth up to seven days of incubation. Of the 84 C. albicans isolates, 77 (91.6%) inoculated on hypertonic SGA showed growth at 72 hours of incubation and the remaining seven at 96 hours. On Staib agar, 19 of the 20 test C. dubliniensis iso-
Image: Scanning electron micrograph (SEM) of candida (Photo courtesy of D. Phillips / Science Photo Library).
Concentration of Tumor Protein Predicts Metastatic Cancer
olecular techniques have revealed that high levels of a particular protein in tumor cells are a reliable indicator that the cancer will metastasize. By measuring a protein biomarker in a tumor and comparing the levels in surrounding tissue, it is possible to predict whether the cancer will spread to other organs within two years. Scientists collaborating with the University of Hong Kong, (Hong Kong SAR, China; www.hku.hk) studied the protein carboxypeptidase E (CPE) in a form known as CPEdelta N. CPE-delta N, a variant of CPE, and is present in high amounts in tumors that have spread, and only in small amounts in the surrounding tissues. Ordinarily, CPE is involved in processing insulin and other hormones. They tested for CPE-delta N indirectly, by measuring levels of ribonucleic acid (RNA). RNA works with the information in a gene to make a particular protein as in this case, CPE-delta N. In an analysis of tissue from 99 patients with liver cancer, they compared the amount of CPE-delta N RNA from the patients tumors with the RNA levels in surrounding tissue. The status of the patients morbidity was tracked for up to eight years. The scientists found that when the level of CPE delta-N RNA in tumors was more than twice that in the surrounding tissue, the cancer was highly likely to return or to metastasize within two years. At or below this threshold level, the can-
cer was much less likely to recur. Using this threshold measure, the investigators accurately predicted metastasis or recurrence in more than 90% of the cases. Conversely, their predictions that tumors would not return in the two-year period were accurate 76% of the time. They also measured CPE-delta N RNA levels from stored tumor tissue originally removed from 14 patients with pheochromocytoma, a rare tumor of the adrenal glands, and paraganglioma, a rare tumor primarily occurring in the adrenals but sometimes in other parts of the body. The number of copies ranged from 150,000 to 15 million per 200 micrograms of tissue. In all of the cases where cancer was found to have recurred or metastasized, CPE-delta N RNA levels were greater than one million. The researchers found no metastasis or recurrence in cases in which tumors had less than 250,000 copies. In addition, the scientists examined cells from liver, breast, colon, and head and neck, tumors and found that those known to spread most aggressively had the highest levels of CPE-delta N RNA. Y. Peng Loh, PhD, a senior author of the study, explained that the method used in the study might someday be used to treat cancers in human beings. Currently, there are no means to deliver the antisense RNA to tumor cells. A potential approach might involve modifying a virus to carry the antisense RNA into cells. The study was published on February 1, 2011, in the Journal of Clinical Investigation.
lates showed chlamydospore formation at 48 hours of incubation and the solitary remaining isolate at 96 hours. In comparison, most C. albicans isolates did not grow well on this medium. Growth inhibition at 45 C was observed by all of the test and reference C. dubliniensis isolates. However, growth inhibition also occurred in a large majority of the C. albicans isolates at this temperature indicating poor specificity. The authors concluded that their
observations are highly significant in that hypertonic SGA with 6.5% sodium chloride was entirely free from any false positive or false-negative results. The hypertonic SGA was strongly recommended for wider application as a reliable and inexpensive medium for routine differentiation of C. dubliniensis from C. albicans. The study was published online on March 9, 2011, in the journal Diagnostic Microbiology and Infectious Disease.
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BLOOD CLOTTING MONITOR

Microvisk
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The Smartstrip device is a handheld system that monitors the blood clotting status of patients taking the drug Warfarin. The system uses a disposable strip with embedded sensors to measure the clotting speed of blood from a fingerprick sample, with results displayed on the unit.
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Temperature Affects Leukocyte Surface Antigen Expression
low cytometry analysis of leukocyte surface antigens has been used to characterize infectious and septic processes in patients. Factors that affect leukocyte immunophenotyping include sampling and processing temperature, the anticoagulant used, and the storage temperature of the blood sample. Scientists at the University of Oulu (Oulu, Finland; www.oulu.fi) investigated the possible effects of anticoagulant, sample collection, storage and processing temperature, and sample storage time, on the expression of several leukocyte surface antigens. They collected blood from five male patients, aged 44-68, with severe sepsis requiring intensive care and five healthy staff members (two males and three females, aged 22-62). In this study, the patients and
the healthy volunteers were combined into one study population. Blood was collected into siliconized vacuum tubes containing acid citrate dextrose (ACD) or sodium heparin as an anticoagulant and stored either at 4 C or at room temperature (RT). Aliquots of the blood samples were incubated with various antibodies at different temperatures and times and analyzed on a FACSCalibur flow cytometer (BD Bioscience; San Jose, CA, USA; www.bdbiosciences.com). The surface antigens of interest were neutrophilic cluster of differentiation (CD)11b and CD64, monocytic CD11b, CD14, CD40, CD64, CD80 and human leukocyte antigen, HLADR, and lymphocytic CD69 (separately in CD4+ and CD8+ T cells, B cells, and natural killer cells). The fluorescence intensities were
higher at RT than at 4 C. During storage the intensities increased at RT, but at 4 C there were only minor changes. The effects were similar with both anticoagulants studied. The authors concluded that the study shows in a quantitative way that storing the blood samples at RT may have pronounced effects on the intensities of several leukocyte surface antigens, something
which is of interest in leukocyte activation studies, such as patients with sepsis. They recommended that flow cytometric analysis of leukocyte surface antigen expressions should be performed using 4 C temperature throughout the process and within six hours. The study was published online March 15, 2011, in the Journal of Clinical Laboratory Analysis.
Blood Clotting Factors Affect Bowel Cancer Risk
Monoclonal Antibody Microarray Assesses Multiple Protein Levels in Plasma
monoclonal antibody microarray was developed to assess the level of multiple proteins simultaneously in human plasma. Using the QuantiPlasma array it is possible to assess directly the plasma proteome of normal and disease state plasma samples for the identification of novel biomarkers. Each kit contains 300 unique monoclonal antibodies that can be assessed simultaneously using Biochip Array Technology. Currently biomarker discovery by mass spectrometry is an expensive and laborious method, with limitations in reproducibility and sensitivity due to the wide range of protein con-
centrations in plasma and extensive processing requirements. Biomarker validation and follow-on studies can also be impeded by a lack of available immunoaffinity reagents. Randox Pharma Services (Crumlin, United Kingdom; www.randox pharmaservices.com) designed and developed the QuantiPlasma array. The company invested in developing solutions for biomarker discovery because of their broad range of applications for the diagnosis, prognosis, and monitoring of disease progression and the monitoring of clinical responses. The solutions should lead to therapeutic intervention and personalized medicine.
ene variants of different clotting factors were studied for a possible connection with colorectal cancer risk. The occurrence of six variants was analyzed in approximately 1,800 colorectal cancer patients and in the same number of healthy control persons. Scientists at the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ; Heidelberg, Germany; www.dkfz.de) headed by Prof. Dr. Hermann Brenner studied the six gene variants of different clotting factors for a possible connection with colorectal cancer risk. The team found a variant that substantially increases the risk of thrombosis, which is known as factor V Leiden (FVL). Study participants who carry this genetic variant on both copies of their chromosome 1 were found to have a six-fold increase in colorectal cancer risk compared to participants who carry two copies of the standard variant of factor V. If only one copy of chromosome 1 had the FVL variant, bowel cancer risk was not elevated. Another connection with bowel cancer prevalence was found by the
team for a particular gene variant of clotting factor XIII: people with this mutation are more slightly less affected by venous thrombosis than those who carry the factor XIII standard version. The DKFZ team showed that their colorectal cancer risk is also 15% lower. For the other four gene variants studied, the team found no connection with bowel cancer risk. The knowledge of these connections is the first prerequisite for finding out whether and for whom drugs that affect blood clotting may prevent bowel cancer. It is known that coagulation and carcinogenesis are associated. Thus, the interplay of all coagulation factors leads to the formation of active thrombin, which, in turn, activates hemostatic fibrin. However, thrombin also contributes to the formation of new blood vessels and is able to dissolve the extracellular matrix, which is the adhesive that keeps cells together. Thrombin may thus make it easier for cancer cells to invade surrounding tissue. The study appeared ahead of print in the March 2011 edition of the Journal of Clinical Oncology.
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LabMedica
HLA Primer Sets Achieve High- and Medium-Resolution Genotyping
ew HLA Primer Sets achieve high- and medium-resolution genotyping of class I and class II loci of the Human Leukocyte Antigen (HLA) genes. Introduced by 454 Life Sciences (Branford, CT, USA; www.454.com), a Roche Company, the new GS GType New HLA Primer Sets are designed for use with the companys benchtop GS Junior and GS FLX next-generation sequencing systems enabling high-resolution typing and unambiguous allele assignment in a single run. The kits are the first in a series of assays in the areas of immunogenetics, infectious disease, and cancer to be launched for use with 454 Sequencing Systems, allowing scientists to integrate easily the platforms into application-specific laboratory workflows. The HLA genes encode for the immune system proteins that recognize foreign cells and other antigens. Accurate characterization of an individuals HLA type is important for tissue transplantation matching, while variations in these genes have known association with a wide variety of
autoimmune diseases, infectious diseases, and some cancers. The long, clonal reads provided by 454 Sequencing Systems enable straightforward high-resolution of multiple samples at a time. In many cases HLA typing achieves unambiguous allele identification within a single sequencing run. Sequence output is compatible with third party HLA genotyping software tools offering scientists a complete solution from DNA to genotype assignment. Genotyping of HLA genes can be challenging because of the highly polymorphic nature of this region of the human genome. Traditional sequencebased typing using Sanger capillary electrophoresis technology is unable to resolve ambiguities and set phase without requiring multiple iterations, interspersed with significant manual analysis of the data, and often the use of multiple technologies. The GS GType HLA Primer Sets are the result of an extensive multisite study, which was published March 2011 in the journal Tissue Antigens.
454Sequencing Systems offer a major advance for high-resolution, high-throughput HLA typing, explained Henry Erlich, PhD, senior study author and Director of the Department of Human Genetics at Roche Molecular Systems. The ability to quickly achieve such high accuracy and resolution will have a significant impact on research and, ultimately, on clinical application of HLA typing.
Image: The GS GType HLA MR Primer Set (blue label) and GS GType HLA HR Primer Set (yellow label) each contain four 96-well plates (Photo courtesy of 454 Life Sciences).
DNA Methylation Patterns Accurately Detect Early Bowel Cancer
cientists have discovered that DNA methylation patterns, a key process in cell development, could accurately detect early bowel cancer. Investigators from Cancer Research UKs Cambridge Research Institute (Cambridge, United Kingdom; www.cambridgecancer.org.uk) analyzed 261 tumor samples taken from patients who had either benign bowel polyps or had developed bowel cancer. They found that DNA methylation patterns of two genes called SFRP2 and IGF2 identified and distinguished between tumors and benign polyps,
with an accuracy of more than 90%. Levels of an enzyme called DNMT3B, which helps add methyl groups to DNA, were also measured. Enzyme levels in tumor samples increased from lower amounts present at the polyp stage to higher levels in bowel cancer. The increase in enzyme levels corresponded with the increased amount of DNA methylation and provided an explanation for the changes. Dr. Ashraf Ibrahim, lead author of the study, which was published online in Gut on November 10, 2010, said, The molecular signals, which tell
genes whether to make proteins or not, can become jumbled in cancer cells. Weve identified several places where this signal becomes damaged and shown this is linked to bowel cancer development. The majority of bowel cancers develop from benign polyps that turn cancerous - and this crucial research deepens our understanding of the molecular changes behind this development. This first step in detecting molecular flags for bowel cancer, could, one day, lead to a simple test to search DNA for the early signs of the disease.
Bilirubin Assay for Neonates Takes Only 60 Seconds
neonatal total bilirubin assay requires only 100 L of blood and offers test results in about 60 seconds. The neonatal total bilirubin (nBili) test is performed on the RAPIDPoint 405 blood gas analyzer with software version 3.7. With one small blood sample, a full range of analytes can be measured including bilirubin, blood gases, electrolytes, glucose, total hemoglobin, and other critical care parameters required to assess critically ill infants. The RAPIDPoint 405 offers a no-maintenance, cartridge-based solution for critical care testing of whole blood unlike the reagent-based chemistry analyzers that require the separation of plasma from the red blood cells prior to analysis. Ease of use, minimal sample size, and fast turnaround of test results enhance patient care. Siemens (Erlangen, Germany; www.medical.siemens.com) nBili test on the RAPIDPoint 405 Blood Gas Analyzer is intended to measure the concentration of bilirubin in an infants blood as an aid for assessing the risk for kernicterus in a point-of-care setting. Kernicterus is due to marked jaundice in the newborn period. The high blood level of the pigment bilirubin results in its deposition in the brain, which damages the brain. Today, no baby should develop brain damage from untreated jaun-
dice. If a baby gets too jaundiced, the baby can be treated with phototherapy. The baby can be put under blue lights most of the day. If the baby gets
very jaundiced, an exchange transfusion can be done. Kernicterus is also called bilirubin encephalopathy.
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The HM-JACKarc fecal occult blood test analyzer features a rack system intended to achieve enhanced operability and increase throughput speed. Other key benefits include a full-color indicator that allows users to visually monitor operating conditions by patterns of emission.
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Testing Pregnant Mothers Prevents Congenital Syphilis
ongenital syphilis is easily prevented by testing mothers while they are pregnant. Testing should occur at the first prenatal visit and in communities where the risk is high; it should be repeated during the third trimester and once more at delivery. Mothers who are diagnosed with syphilis during pregnancy can be treated to prevent syphilis infection of the baby. Syphilis is caused by the sexually transmitted bacteria known as Treponema pallidum. Sexually transmitted diseases (STDs) including syphilis, chlamydia, gonorrhea, herpes, human papillomavirus (HPV), and human immunodeficiency virus (HIV) can be transmitted to infants during pregnancy. A study of 41,000 women, published in the early online edition of the Lancet Infectious Diseases on June 16, 2011 showed that testing and antibiotics could more than halve the number
of deaths of babies whose mothers were suffering from syphilis. The UK experts said screening was cheap and cost-effective. The study was lead by Dr. S. Hawkes PhD, reader in global health, UCL Institute for Global Health and Center for International Health and Development, University College London (United Kingdom; www.ucl.ac.uk). Congenital syphilis in infants can result in stillbirth, premature delivery, low birth weight, and significant birth defects (bone, blood, brain, heart). Syphilis causes 500,000 stillbirths and newborn deaths globally, mostly in Sub-Saharan Africa.
Image: Colored Transmission Electron Micrograph (TEM) showing a Treponema pallidum bacterium (Photo courtesy of Alfred Pasieka / Science Photo Library).
Simple Urine Test Diagnoses Prostate Cancer
test has been developed that can detect a specific protein in the urine of men that is linked to prostate cancer. A small sample is used to find whether the protein is secreted into the urine where it can be easily detected using the new test that is simple, quick and has the potential to be used in family physicians surgeries. Scientists at the University of Surrey, (Guildford, UK; www.surrey.ac.uk), tested 194 urine samples for the presence of a protein called Engrailed-2 (EN-2), between June 2007 to June 2010. Included in the study participants were men with lower urinary tract symptoms, individuals concerned they may have an asymptomatic prostate cancer, for instance having a positive family history, and men with an abnormal prostate specific antigen (PSA) test. Two groups of controls were also tested. Samples were assayed using an in house enzyme-linked immunoassay (ELISA) that used two mouse monoclonal anti-
bodies. Other studies were conducted to detect the presence of EN-2 included Western blot, and semiquantative polymerase chain reactions (RTPCR). The stability of En-2 protein in urine was shown to be at least four days at room temperature, allowing postal collection of some samples. EN2 protein was detected in 54 of the 82 (66%) men with prostate cancer confirmed by biopsy, using a cutoff point of 42.5 g/L, and in nine men in this EN2 positive group, their PSA was less than 2.5 ng/mL. The authors reported that using the 42.5 ng/mL cut off point, the EN2 test has a sensitivity of 66% and a specificity of almost 90%. The potential utility of EN2 as a prostate cancer biomarker was demonstrated by its presence in the urine of men with low PSA of less than 2.5 g/L, but histologically confirmed prostate cancer on biopsy. The ELISA based assay for EN-2 will potentially allow a number of different detection platforms
including a lateral flow application with a dip stick test, which could be performed quickly and cheaply in primary care or as a component of a large-scale screening program. EN2 is an important protein in the development of the human embryo and, like many similar fetal proteins, its production is switched off at birth. However, this study showed that EN2 is switched back on again in prostate cancer. Hardev Pandha, MD, PhD, professor of oncology at the university, said, In this study we showed that the new test was twice as good at finding prostate cancer as the standard PSA test. Only rarely did we find EN2 in the urine of men who were cancer free, so if we find EN2 we can be reasonably sure that a man has prostate cancer. EN2 was not detected in men with noncancer disorders of the prostate such as prostatitis or benign enlargement. The study was published on March 1, 2011, in the journal Clinical Cancer Research.
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Monoclonal Antibodies Produced for Alzheimers Blood Test

onoclonal antibodies (mAbs) were successfully produced for a diagnostic blood test for Alzheimers disease (AD). A simple, easy to use diagnostic blood test for AD is ready for clinical testing. Human sample testing has begun and will run over the next few months. biOasis Technologies Inc. (Vancouver, BC, Canada; www.bioasis.ca) announced the completion of a project intended to produce proprietary monoclonal antibodies (mAbs) for its Cognitest blood test for Alzheimers disease. Working in collaboration with Fleet Bioprocessing (Hartley Witney, United Kingdom; www.fleetbioprocessing.co.uk), and OxFabs (Oxford, United Kingdom; www. oxfabs.com), the company generated numerous antibodies and assessed their performance in prototype assays. The best performing mAbs were selected for use within production prototypes. Current initiatives within the Cognitest program include product and method development, validation using human samples, and regulatory approval in Europe. To enable faster adoption and greater use of Cognitest the company intends to out-license it to leading in vitro diagnostic companies.
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blood test for low-density lipoprotein (LDL) particles is a more accurate predictor of cardiovascular disease (CVD) events than LDL cholesterol (LDL-C). A high value proprietary blood test using nuclear magnetic resonance (NMR) technology has demonstrated that the amount of cholesterol per low-density lipoprotein particle (LDL-P) is variable and related in part to particle size, with smaller particles carrying less cholesterol. Scientists at Wake Forest University School of Medicine (Winston-Salem, NC, USA; www.wfu. edu) analyzed blood samples obtained at study onset from 5,598 middle-aged men and women free of cardiovascular disease, who participated in a prospective observational study. Participants were followed for a mean of 5.5 years for incident CVD events, including heart attack, coronary heart disease death, angina, stroke, stroke death, or other atherosclerotic or CVD death. Of 319 total CVD events recorded, 159 occurred in persons with LDL-C and LDL-P numbers that disagreed. The CVD risk of these individuals tracked with LDL-P number regardless of levels of LDL-C and only LDL-P numbers were associated with incidence of CVD. LDL particle levels were measured using the NMR LipoProfile test (LipoScience Inc., Raleigh, NC, USA; www.liposcience.com). LDL-P information can help clinicians personalize and refine LDL treatment decisions, particularly to minimize residual risk in patients with low LDL-C levels. Clinicians historically have used the LDL-C level, the amount of cholesterol carried within LDL particles, to determine how much treatment, if any, a patient needs. The study was published online on February 14, 2011, in the Journal of Clinical Lipidology.
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The Instrument Manager is designed to provide simplicity, flexibility, and system connectivity for better management and control of all lab operations.
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The flexible ProCode solution enables the rapid isolation of target-specific antibodies without common laborintensive screening, and creates diagnostic antibodies.
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Enzymatic creatinine is a two-part liquid-stable reagent that offers enhanced precision, and eliminates common interference found in Jaffe methods.
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The AESKULISA is a complete panel for autoimmune diabetes testing, including determination of autoantibodies against IA2, GAD65, and insulin.
The L-Arginine ELISA is designed for the determination of L-Arginine in human EDTAPlasma, to monitor the arginine balance in cardiovascular risk patients.
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Urine Biomarker Helps Predict Delayed Graft Function
diagnostic test for early detection of acute kidney injury helped predict delayed graft function (DGF) in kidney transplant patients. A study examined how serial urine neutrophil gelatinase-associated lipocalin (NGAL) concentrations change over time following kidney transplants and whether urine concentrations of NGAL could predict the onset of delayed graft function or prolonged delayed graft function. One-hundred and seventy-six renal transplant patients were evaluated in the study. Urine samples were collected before transplantation and for several
days afterward. Seventy patients had DGF and 26 of them were prolonged. The NGAL assay was performed by a two-step chemiluminescent microparticle immunoassay on the Architect standardized clinical platform of Abbott Diagnostics (Abbott Park, IL, USA; www.abbott.com). The patients who developed DGF had a significantly slower decrease in urinary NGAL compared to those without DGF. Urine NGAL levels measured a day following transplant predicted prolonged DGF (14 days or longer), which had significantly worse one-year graft survival (73 %) compared with shorter
DGF (100 percent). The scientists concluded that urine NGAL measurements could predict prolonged DGF and identify patients with severe kidney injury and inferior long-term organ survival. They added that the test also provides a simple method to quantify recovery from kidney injury. The Finnish study was published in the September 2010 edition of Kidney International, the journal of the International Society of Nephrology. Abbott (Abbott Park, IL, USA; www.abbott.com) introduced the automated urine NGAL assay in Europe on Architect, the companys flagship instrument system.
Plasma Biomarkers Identified in Patients with Metastatic Melanoma

set of plasma biomarkers reasonably predicted the risk of metastasis among patients with melanoma. Scientists tested the plasma of 216 individuals, including 108 patients with metastatic melanoma and 108 patients with stage 1 or 2 disease. They identified seven plasma biomarkers: CEACAM, ICAM-1, osteopontin, MIA, GDF-15, TIMP-1, and S100B. All of the biomarkers were higher in patients with metastatic melanoma than in patients with early-stage disease. Seventy-six percent of patients with early-stage disease had no elevations at all whereas 83% of metastatic patients had elevations of at least one marker. The investigators from Yale University School of Medicine (New Haven, CT, USA; http://medicine. yale.edu) concluded that these biomarkers could be used for monitoring melanoma patients for metastatic disease. However, the findings need to be confirmed prospectively before the biomarker set can be used in the clinic. Melanoma is the fifth most com-
New OB/GYN Products Designed for Clinical Reproductive Health Needs

comprehensive portfolio of in vitro and in vivo products for obstetrics and gynecology (OB/ GYN) patient management features both clinical laboratory diagnostic solutions and ultrasound imaging. The products were designed to help physicians deal with the clinical reproductive health needs of patients. Siemens Healthcare (Erlangen, Germany; www.medical.siemens. com) displayed its integrated solutions for OB/GYN patient management at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), held in Washington DC (USA) from April 30-May 4, 2011. Highlights of Siemens OB/GYN diagnostic solutions that were unveiled at the meeting included the Immulite 1000 Immunoassay System and the latest Loci fertility assays available on Dimension Vista Intelligent lab systems. The Immulite benchtop analyzer is engineered for easy operation and reliability. It offers
mon cancer in men and the seventh most common cancer in women. It is estimated that 68,130 people in the United States were diagnosed in 2010, and 8,700 died. If melanoma is caught early enough it can be removed with surgery; mortality typically comes when the cancer metastasizes. Patients with melanoma are typically subjected to a combination of imaging tests, blood tests, and physical examinations, but there is no clear consensus on how often these tests should occur or how reliable they are. The rate at which melanoma is increasing is dramatic, and there is a huge number of patients under surveillance, said Harriet Kluger, MD, associate professor of medicine at Yale University School of Medicine. Our current method of surveillance includes periodic imaging, which creates huge societal costs. The study was published in the April 15, 2011, edition of the journal Clinical Cancer Research.
an extensive menu for routine and specialty immunoassay testing, including Siemens broad range of reproductive endocrinology assays, such as estradiol, progesterone, and testosterone. Information about Siemens full line of reproductive endocrinology platforms including the ADVIA Centaur Immunoassay Systems, Dimension integrated systems, and Immulite 2000 immunoassay system, was also available at the meeting. Loci technology requires fewer reaction steps resulting in fast turnaround times. The Loci assays include luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin. LH and FSH are useful in the clinical evaluation of gonadal and pituitary disorders, while prolactin is used in the diagnosis and treatment of disorders of the anterior pituitary gland and hypothalamus portion of the brain. Several of Siemens ultrasound imaging solutions for OB/GYN care were also introduced at the meeting.
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Multigene Tests Compared for Breast Cancer Prognosis
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wo multigene assays were examined to calculate their agreement in predicting the prognosis in different types of breast cancer. Several commercial assays are being introduced to assign clinical subtype or predict risk of recurrence for breast cancer of which there are at least four different subtypes with clinical relevance. Scientists at Mater Misericordiae University Hospital (Dublin, Ireland; www.mater.ie) extracted ribonucleic acid (RNA) from 119 formalin-fixed, paraffin-embedded tissue blocks from breast cancer patients who have been classified as being at clinically intermediate risk for recurrence based on several criteria: median tumor size 1.5 cm, all estrogen receptor (ER)-positive, Human Epidermal growth factor Receptor 2 (HER2) -negative, lymph-node negative and most of them were classified as grade II. Working with colleagues in the USA, the scientists performed the PAM50 Breast Cancer Intrinsic Classifier Reverse Transcription/Quantitative Polymerase Chain Reaction and compared it to the OncotypeDX recurrence score (RS) assay. The results showed that all patients with high RS according to the OncotypeDX were classified as luminal B or basal-like by the PAM50 classifier, whereas 83%, the majority of low RS cases were luminal A type. Half of the Intermediate RS cancers were recategorized as low risk luminal A cancers by the PAM50. All luminal A cancers are either low (70%) or intermediate (30%) risk by RS, whereas luminal B cancers are comprised of a mixed risk group by RS including 33% that are high risk by OncotypeDX. These results indicate that there is a reasonably good agreement between the two methods for high and low prognostic risk assignment. According to the authors of the study, intermediate risk groups by one assay often include cases with discordant risk prediction by the other method. When discordant risk results are obtained it is currently unknown which assay will predict outcome more accurately. The OncotypeDX test (Genomic Health; Redwood City, CA, USA; www.genomichealth. com) is intended for use in patients with hormone receptor-positive, lymph node-negative breast cancer to identify women at low risk of breast cancer recurrence who can safely avoid chemotherapy. It measures the activity of 21 genes and generates a recurrence score (RS) which categorizes patients into low, intermediate or high risk groups depending on the risk of distant recurrence. The PAM50 breast cancer intrinsic classifier, (ARUP Laboratories; Salt Lake City, UT, USA; www.aruplab.com) measures the expression of 50 genes and stratifies breast cancers into five subtypes; luminal A, luminal B, basal-like, Her2enriched and normal-like, so the target population is not just patients with ER-positive breast cancers. This test is currently undergoing clinical validation. The study was presented at the Improving Care and Knowledge Through Translational Research (IMPAKT) Breast Cancer Conference, 5-7 May, 2011, held in Brussels (Belgium).
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LabMedica
Rapid Blood Test Detects Myocardial Infarction
sensitive assay has been used to detect myocardial infarction (MI) within two hours of a patient being admitted to hospital. An increase in the concentration of troponin in the blood is used to detect whether patients with acute coronary syndrome (ACS) have myocardial infarction and this can be used as a diagnostic marker. A study performed at the Catharina Hospital (Eindhoven, The Netherlands; www.cze.nl) examined the concentration of troponin in 157 patients with suspected nonST elevated ACS. Blood was drawn on arrival (T0) and 2 (T2), 6 (T6)
and 12 (T12) hours later. Levels of cardiac troponin I, creatine kinasemyocardial band fraction (CK-MB) and myoglobin were measured on an immunochemistry analyzer. The assay for troponin was the second-generation TnI-Ultra troponin kit and all tests were analyzed on the manufacturers Advia Centaur analyzer (Siemens Healthcare Diagnostics; Erlangen, Germany; www.medical.siemens.com). The TnI-Ultra troponin kit is a second generation, high-sensitivity test with a 10% coefficient of variation (CV) at 0.05 g/L and a troponin concentration of 0.06 g/L
at the 99th percentile of a reference population. The 99th percentile was established on 221 samples from outpatients with no history of myocardial disease. At T2, a troponin concentration above the MI cutoff is 87% sensitive and 100% specific for MI detection. A difference of more than 30% between the troponin measurements at T0 and T2 in the absence of an absolute troponin increase above the 99th percentile of a reference population was also considered
indicative of MI, the sensitivity increases to 100% and specificity decreases to 87%. The authors concluded that by using a sensitive troponin assay and simple algorithms, the diagnosis of MI can be determined within two hours after arrival at the emergency department, and the measurement of myoglobin and creatine kinase MB has no added value. The study was published in March 2011 in the American Journal of Clinical Pathology.
Kit Provides Quantitative Determination of Haptoglobin in Human Serum
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ured turbidimetrically at 340 nm. A wide measuring range of 0.13 g/L to 3.68 g/L ensures that the assay is capable of accurately measuring above and below the patient normal range while an extended onboard stability of 28 days minimizes reagent waste. The assay is precise, traceable to certified reference material, and has limited interference from bilirubin, hemoglobin, and triglycerides. Prozone effects are not demonstrated up to at least 7.64 g/L and the assay shows excellent correlation to standard methods. In addition to quality controls, Randox also offers a specific protein EQA program providing customers with a complete quality management solution. The bi-weekly RIQAS program comprises 26 proteins and allows assessment of analytical performance in comparison to other laboratories using the same method/instrument.
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Edited by Edgard Delvin, Ph.D., FCACB

IFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5 Tel: (1) 514-345-4831 (ext. 5635); E-mail: edgard.delvin@recherche-ste-justine.qc.ca
NEWS
IFCC Executive Board (2012-2014)
Presidents Report from the 2011 IFCC Council Meeting

by Dr. Graham Beastall, President, IFCC
he Council is the overall governing body of IFCC. It meets once every three years, usually in association with the IFCC WorldLab congress. Accordingly, the 2011 IFCC Council meeting was held on Sunday May 15, in Berlin. Approximately 100 people, including 57 representatives from IFCC Full Member National Societies who were empowered to vote, attended the Council meeting.
Presentations
The first part of the Council meeting was chaired by Paivi Laitinen (Honorary Secretary) and comprised reports from: Graham Beastall, President; Chris Lam, Vice President; Ghassan Shannan, Treasurer; Joseph Pasarelli, Corporate Member representative; Ian Young, Chair of Scientific Division; Janet Smith, Chair of Education & Management Division; Ellis Jacobs, Chair of Communications and Publications Division Copies of all these reports are available from the Executive Board section of the IFCC website www.ifcc.org
Election of Executive Board for 2012-2014:

Professor Jocelyn Hicks (Past President) conducted the election of the next Executive Board. The following individuals were elected to serve from January 1, 2012, until December 31, 2014: President: Graham Beastall (UK) Vice President: Howard Morris (AU) Secretary: Sergio Bernardini (IT) Treasurer: Bernard Gouget (FR) Member: Ulisses Tuma (BR) Member: Vanessa Steenkamp (ZA) Member: Larry Kricka (US) In addition, Jocelyn Hicks (US) will continue as Past President for the duration of the next Executive Board. A photomontage of the new Executive Board is shown. The new Executive Board includes four new faces. Short biographies of each of these newly appointed individuals are included.
Prof. Howard Morris, Australia: Newly Elected Vice President of IFCC

Prof. Howard Morris is Professor of Medical Science at the University of South Australia and a Chief Medical Scientist in Chemical Pathology at SA Pathology, Adelaide Australia. He leads a research group investigating the pathophysiology of metabolic bone disease and the effects of hormones, including vitamin D, funded by the National Health and Medical Research Council and Australian Research Council, the major competitive funding bodies in Australia. His latest work has identified the basis for vitamin D requirement to reduce the risk of fractures among the elderly. He was invited to present the Louis Avioli Memorial Lecture at the 2009 Annual Scientific Meeting of the American Society for Bone and Mineral Research on this topic. He is also Deputy Chair of a South Australian Department of Health Working Party on Osteoporosis and Fracture Prevention. He has 18 years experience working in diagnostic clinical biochemistry in the field of immunoassay and endocrinology and continues an active professional life in laboratory medicine. Between 2002 and 2008, he was the secretary of the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and a member of the IFCC Task Force on the Global Campaign on
Contd on page 44
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NEWS
Contd from page 43
News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
Presidents Report from the 2011 IFCC Council Meeting

preclinical testing of traditional herbal remedies, which includes the isolation of active compounds and development of new drugs. Vanessa is the author and coauthor of over 60 scientific papers. She has received a number of awards for her research both nationally and internationally, among which is the prestigious Friedel Sellschop award, formerly known as the University of the Witwatersrand Young Researcher in 2001 and Exceptional Young Researcher of the University of Pretoria in 2006, two of the leading academic institutions in the country. In 2007, she received two international awards in her recognition to research as a young scientist: from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology and the American Association of Clinical Chemistry. Currently she is supervising 15 postgraduate students. She is the president of the African Federation of Clinical Chemistry, vice-president of the Toxicology Society of South Africa, secretary-general of the South African Association of Basic and Clinical Pharmacology, treasurer of the Federation of the South African Society of Pathologists and past president of the South African Association of Clinical Biochemistry. She serves as reviewer for 18 international peer-reviewed journals and is on the editorial board of 4 journals. She has 149 conference contributions and has been the invited speaker on 16 occasions. Vanessa is the mother of four boys; triplets Brendon, Dylan, Lance (10) and Jacques, 14. Both herself and husband, Johan are very involved with coaching of children in school sports. She is the manager of a provincial chess team (under 16). She thoroughly enjoys gardening and nature and spends her free time reading.
Diabetes Mellitus. He currently is a member of the IFCC Task Force on International Clinical Liaison. Between 2003 and 2009, he was the director of the Hanson Institute in Adelaide, South Australia.
Changes to the Governance:

Under the chairmanship of the President, the Council considered and voted on a number of proposals for changing the governance and operation of IFCC. Council approved: President Elect: At the next Council elections in 2014, the post of Vice President will be discontinued. The President Elect will replace it. Terms of Office for President Elect and Past President: With effect from January 2015, the term of office of the Past President will be reduced from three years to two years. The President Elect will be elected at a time that enables him/her to take over from the Past President and serve for the final year of an Executive Board, before submitting himself/ herself for election as the next President Electronic Voting: The next Council elections for the Executive Board that will commence in 2015 will be conducted by an electronic ballot of Full Members rather than by personal vote at the Council meeting. The IFCC Rules and Statutes will require amendment to permit these changes in governance. That will be a task for the next Executive Board. Membership Subscription: The Council noted that the membership subscription had remained unchanged for 12 years. It then agreed to an increase in the baseline membership subscription from 6.0 to 6.5 Swiss Francs per member of the National Society. This revised membership subscription will apply from 2012 and last for at least three years. In order to soften the financial burden a little the Council also agreed to a modest differential according to the wealth of the country as defined by the World Bank. Therefore, the membership subscription that will apply will be: 6.5 Swiss Francs per member in High Income countries; 6.0 Swiss Francs per member in Upper Middle Income countries; 5.5 Swiss Francs per member in Lower Middle Income countries; 4.0 Swiss Francs per member in Low Income countries IFCC WorldLab 2017: The President announced that the Executive Board, on the advice of the Committee for Congresses and Conferences, had selected Durban in South Africa as the host city for IFCC WorldLab 2017.
Prof. Sergio Bernardini, Italy: Newly Elected Secretary of IFCC

Prof. Sergio Bernardini MD, PhD, currently is a full professor of Clinical Biochemistry and Clinical Molecular Biology at the Department of Internal Medicine of the University of Rome Tor Vergata, and the head physician of the Clinical Molecular Biology Unit at the Tor Vergata University Hospital. He received his degree in Medicine in 1986 and the PhD in Pediatric Sciences in 1995. He has specialized in Pediatrics (1990) and in Clinical Chemistry and Biochemistry (1998). He act as the president of the undergraduate course in "Diagnostic laboratory techniques in the medical field," and, as a clinical laboratory research consultant with Bambino Gesu Childrens Hospital in Rome. He is a member of the Italian Society of Clinical Biochemistry (SiBioC), where he forms part of the committee of Clinical Molecular Biology, as well as the Italian Society of Biochemistry (SIB) and the Italian Society of Allergology and Immunology (SIAIC). His international activities include membership of the Editorial Advisory Board of The Encyclopedia of Life Sciences. As a professor, he has several teaching responsibilities including a Bachelors course in diagnostic laboratory techniques in the medical field, degree courses in medicine, medical biotechnologies, movement sciences and postgraduate courses in Clinical Biochemistry, Gastroenterology, Neurology, Medical Genetics, Allergology, and Immunology, and Pediatrics. His research interests are diverse in nature and have included work in pediatric endocrinology with particular interest in growth hormone and insulin like growth factors and their binding proteins. He has also worked on apoptotic pathways in oncology, in particular neuroblastoma, as well as on glutathione transferases, a family of enzymes involved in cell detoxification and in the control of the programmed cell death. He has collaborated in the application of molecular biology and proteomic methods and techniques in research applied to neurodegenerative diseases, oncology, and pharmacogenetics. Since 2009, he has collaborated in the application of molecular biology and biochemical methods to monitoring of sport training and performance. Sergio is married to Elisabetta since 1998 and has a son, Andrew 21 years old, and a daughter Marta aged 19. His personal interests include football, the theatre, and travelling.
Prof. Larry J. Kricka, USA: Newly Elected Member of IFCC EB

Larry J. Kricka D. Phil., FACB, CSci, CChem, FRSC, FRCPath., is professor of Pathology and Laboratory Medicine at the University of Pennsylvania and director of the General Chemistry Laboratory and Director of the Critical Care Laboratory at the University of Pennsylvania Medical Center. Awards and honors include the Society of Analytical Chemistry Silver Medal (Royal Society of Chemistry) (1981), British Technology Group Academic Enterprise Competition Award (1985), Prince of Wales Award for Innovation and Production (1989), Queens Award for Technological Achievement (1990), Rank Prize for Optoelectronics (1991), the AACC Award for Outstanding Contributions to Clinical Chemistry in a Selected Area of Research (1998), and the Ullman Award (2006). In 2002 Dr. Kricka was the Distinguished Visiting Scholar at Christ's College, Cambridge, England. Research interests include analytical applications of bioluminescence and chemiluminescence, DNA probe assays, analytical microchips for genetic and other types of testing, analytical applications of nanotechnology, analytical interferences caused by heterophile antibodies and direct to consumer testing. Dr. Kricka holds over 30 US patents, and is the author/coauthor of over 500 articles, abstracts, book chapters, and papers, and 22 books. He is editor-in-chief of Luminescence, a member of the editorial board of Clinical Chemistry, Labon-a-Chip, and Analytical Biochemistry, and past editor of the Journal of Immunoassay. He was president of the American Association for Clinical Chemistry in 2001, and is currently president of the International Society for Bioluminescence and Chemiluminescence and will be a member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Executive Board beginning in 2012.
Nomination of the Editor-in-Chief of the IFCC eJournal

Gabor L. Kovacs MD, PhD, DSc, professor of laboratory medicine at the University of Pecs (Hungary) has been appointed as the new editor of the eJIFCC. Professor Kovacs is the Director of the Institute of Laboratory Medicine and Vice-Rector of research and innovation of the University of Pecs, the oldest Hungarian university founded in 1367. Between 2000 and 2007, he was member-at-large of the Executive Committee of the Forum of European Societies of Clinical Chemistry (FESCC). His research interests are related to early diagnostic markers in endocrinology and neuroendocrinology. He has published 431 original papers and in response, obtained more than 5,000 citations. Since 2004, Dr. Kovcs is a member of the Hungarian Academy of Sciences. The professor succeeds Prof. Grazyna Sypniewska who has led the eJournal for the past 6 years. His tenure will start on January 1, 2012.
Prof. Vanessa Steenkamp, South Africa: Newly Elected Member of IFCC EB

Vanessa obtained her MSc cum laude in Biochemistry at the University of Pretoria while employed as a junior lecturer. She took up a position at the South African Institute for Medical Research, now the National Health Laboratory Services in the Department of Endocrinology. She was appointed Lecturer in the Department of Chemical Pathology, University of the Witwatersrand and obtained her PhD in Clinical Toxicology. She returned to the University of Pretoria as senior lecturer in the Department of Urology and transferred to the Department of Pharmacology as head of the Phytopharmacology Unit. Vanessas research interest focuses on traditional herbal remedies and their effect on patients, as well as the development of methods for the detection of these active compounds in biological fluids. She is also involved in
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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information
NEWS
14th Serbian Seminar Focuses on Biochemistry Education and Training

by Snezana Jovicic, Institute of Medical Biochemistry, Clinical Center of Serbia, Belgrade, Serbia
he Society of Medical Biochemists of Serbia organizes every year educational seminars supervised by the Chamber of Biochemists and carries six CME credits. The 14th educational seminar entitled Education of Medical Biochemists and Improvement of Work Quality was held last April. The lectures were Postgraduate Qualification in Pharmacy: Tempus PQPharm Project Goals and Harmonization with the EU, by Prof. Dr. Jelena Parojicic (Faculty of Pharmacy, University of Belgrade, Serbia), The development of Standardization Business and Integrated Management System, by Prof. Dr. Vidosav Majstorovic (Faculty of Mechanical Engineering, University of Belgrade, Serbia), The Needs, Rules, and Process of Continuing Medical Education, by Prof. Dr. Svetlana Ignjatovic (Faculty of Pharmacy, University of Belgrade, and Institute of Medical Biochemistry, Clinical Center of Serbia, Serbia) and Dr. Velibor Canic (Chamber of Biochemists of Serbia, Serbia). Prof. Dr. Nada Majkic-Singh (Faculty of Pharmacy, University of Belgrade, and Institute of Medical Biochemistry, Clinical Center of Serbia, Serbia) talked about Education and Recognition of Professional Qualifications in the Field of Medical Biochemistry of Serbia. In addition to these distinguished speakers from Serbia, we were honored and very pleased to have two lecturers from the EC4 Register Commission Dr. Simone Zerah and Ms. Janet McMurray. The President of the EFCC Professional Committee and Chair of the EC4 Register Commission, Dr. Simone Zerah, spoke on the EC4 Register for Specialists in Laboratory Medicine. She highlighted the structure and the perspective of the EC4 Register, described the aims of the Commission, and stressed the importance of choosing the right name for the profession and of the relations with the European Commission and Parliament. She also introduced the foundations of the Register EC4 Syllabus (which is in accordance with ISO/EN/15189 Standard and the European Directive on the recognition of professional qualifications) and the Code of conduct (representing the ethical values required for professional behavior), and of the Self-Regulation Database of the European Economic and Social Committees Single Market Observatory (EESC/SMO). Dr. Zerah finally emphasized that the Register enables promotion of the profession of specialist in laboratory medicine in the EU and strengthens our influence at the European Commission and the Parliament. EC4 Register Commission Secretary, Janet McMurray, elaborated about the implementation of the EU Directive on recognition of professional qualifications as applied to specialists in clinical chemistry and laboratory medicine. In her lecture, Ms. McMurray talked about systems for recognition of qualifications and Directive 2005/36/EC of the European Parliament on the recognition of professional qualifications, its effects on specialists in laboratory medicine, common platforms, education, and training levels, as well as training contents in European countries, with the review of current status of common platforms and their future. Prof. Dr. Nada Majkic-Singh followed these
excellent lectures by presenting the situation of the recognition of professional qualifications in the field of medical biochemistry in Serbia. In her talk, Prof. Majkic-Singh presented the syllabus of pharmacy-medical biochemistry of the University of Belgrade Faculty of Pharmacy, as well as the professional program of specialization and academic doctoral studies in medical biochemistry, the conditions and regulations for prac- Photo: Lecturers on Seminar from left to right: S. Ignjatovi, V. tice and for recognition of foreign higher Cani, J. McMurray, N. Majki-Singh, J. Paroji, S. Zerah education, together with equivalence of form on training requirements. It also gave the standard of education, training and competence in opportunity to realize that Serbian laboratory profescomparison with EC4 standards. sionals were not far removed from their European Overall, this seminar painted a clear picture of the colleagues in terms of their professional programs position of specialists in clinical chemistry and laboand regulations for practice. ratory medicine in Europe today, of the current plat-
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org Web: www.ifcc.org Office Hours: 9.00-13.00 and 14.00-18.00 Staff Members: Paola Bramati, Silvia Cattaneo, Silvia Colli-Lanzi
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EFCC CORNER
European Federation of Clinical Chemistry and Laboratory Medicine

why healthcare workers decide to migrate. Strategies, which promote adequate workforce supply in all countries, should be supported. As EFCC members we can therefore encourage, and as far as possible contribute to, the development and implementation of policies at local, national and European level with the purpose to enhance work force retention and promote accessible and high-quality health care in developed and developing countries. On the other hand, EFCC partners in the laboratory medicine sector acknowledge the possible mutual benefits of migration for workers and employers in sending and receiving countries, deriving from the exchange of practices, knowledge, and experience. Anecdotally, the mobility of health professions is increasing; the economic crisis experienced by some European countries serves to accelerate the phenomenon.
New Opportunities for Health Professional Mobility in the EU

by Dr. Bernard Gouget
SFBC-EFCC Representative; Secretary General International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); IFCC Executive Board Member
he European directive relating to the recognition of professional qualifications needs to be revised by the end of the year to facilitate the mobility of European workers a little more, especially health professionals. The objective is to live and work in any country of the European Union, with the same rights as nationals. This is possible in part thanks to the directive relating to professional qualifications (directive 2005/36/EC), which provides a system for recognizing diplomas from one European country to another. More than 4600 types of professionals are concerned, including doctors, biologists, and nurses, etc. Currently, the European Commission wishes to modernize this text to fix the delays in transposition into national law and the numerous complaints due to time-consuming and poorly transparent bureaucratic procedures in the member countries. The Commission published a Green Paper last June in order to provide new tools for mobility. It revived the idea of European professional cards for the various health professions that should allow access to databases like those of the professional associations of the country of origin. Furthermore, it plans to trigger an alert mechanism throughout the EU as soon as a practitioner has lost his/her right to practice his/her specialty in another member country, or
even to adjust the minimum training requirements in some specialties. Professionals are also invited to express themselves regarding these reforms with the idea of arriving at a legislative proposal by December 2011. Meanwhile, the 2005 directive was not in vain. In fact, more than 10% of the doctors in Austria, Belgium, Spain, Ireland, Norway, Portugal, the United Kingdom (up to 37%), Slovenia, Sweden, and Switzerland are foreigners, according to a study on European health professional mobility conducted by the European Observatory on Health Systems and Policies in 17 member countries, and published last April. There are many reasons for expatriation, including finding the best working conditions or a better salary and staying together with one's spouse. Efficiency also poses problems in some countries, which see their professionals emigrate, leaving them with skill shortages. Accordingly, the European Federation of Public Service Unions (EPSU) and the European Hospital and Healthcare Employers' Association (HOSPEEM) adopted a "code of conduct and follow up on Ethical Cross-Border Recruitment and Retention in the Hospital Sector," so that cross-border recruitment is successful and beneficial for the employers and workers concerned.
Finally, mobility is also approached as an opportunity by some, such as the European Hospital and Healthcare Federation (HOPE) who are trying to promote the exchange of best practices by offering European health professionals a one-month observation internship in another hospital of the EU. Healthcare services are an essential part of the European Social model. This implies a multifaceted strategy that has to take into account the various challenges different countries are experiencing in terms of healthcare shortages and the reasons
IN MEMORIAM
Corneliu Chiriloiu, MD, PhD (1933-2011)
r. Corneliu Chiriloiu, an eminent biochemist in the N Gh. Lupu Institute of Internal Medicine, died on June 21, 2011. He was born in Arges County in Romania, in 1933, and was educated at the faculty of medicine in Bucharest. He carried on a fruitful activity being successively appointed, researcher, senior researcher head of laboratory, devoted his long activity to problems of biochemistry. The most important part of his activity, as a researcher was the introduction of the new tendencies in the methodology of biochemical investigation with wide implications in the studies of general biology and multiple applications in clinical medicine. The laboratory of biochemistry headed until he retired was one of the standard units of the Institute. With his team of workers, he brought important contributions to the value of the study of enzymes in the diagnosis of hepatic, cardiovascular, renal, and hematopoietic diseases. His constant preoccupation was for the standardization of methods used in clinical laboratories. One of his main concerns was organization of postgraduate courses for specialists all over the country. He was co-founder of the Romanian Society of Clinical Laboratory. For four years, he was formerly active president of the Romanian Society of Clinical Laboratory. Dr. Chiriloiu also served for many years as editor in chief of Romanian Journal of Clinical Laboratory and Medical Technique. He helped to develop research programs; he was also an enthusiastic member of many other scientific medical societies. Dr. Chiriloiu devoted a large part of his activity to the training of technicians in which he proved remarkable,
always guided by his concept that the vocation of a teacher should not be conditioned by the accumulation of an avalanche of data, in a more or less restricted field of clinical laboratory, but by a powerful personality able to trace the significant directions in laboratory. The administrative staff of clinical laboratory has appreciated his competence as well as great kindness and understanding. By his studies on the pathology, he has widely contributed to the diagnosis, the methods of prevention, as well as to clinical trials of new drugs. The results of his manifold activities were introduced in more than 200 publications issued in Romanian and foreign periodicals. Dr. Chiriloiu was an invaluable collaborator and a good fellow. Dr. Chiriloiu was a highly committed, highly enthusiastic. He was a model of competence and devotion, kindness and honesty. For his valuable research activity, he was awarded in 2011 the Diploma of Excelence from Romanian Society of Laboratory Medicine. Aside from his lifelong devotion for his professional activity, Dr. Corneliu Chiriloiu was also a keen lover of art and culture. For his untiring research activity and for the permanent help and guidance of many series of biochemists the memory of Dr. Corneliu Chiriloiu will always remain vivid in the mind of his colleagues and collaborators. He was a very kind man, genuinely devoted to the cause of laboratory medicine. His competence and hard work truly set an example for the younger generation.
Contributed by Assoc. Prof. Dr. Manole Cojocaru, President of RSLM

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46
EFCC CORNER
Final Europlan Conference Takes Stock of Progress in National Strategies for Rare Diseases
n 25 February in Rome, Italy, the final conference of the EUROPLAN (www.europlanproject.eu/ Home.aspx) project was held. Europlan, a three-year DG Sanco-funded project coordinated by the Italian National Center for Rare Diseases (Instituto Superiore di Sanita) launched in April 2008, as an instrument to help the European Union Member States (MS) define a strategic plan for rare diseases following the adoption of a Council Recommendation on an Action in the Field of Rare Diseases that calls on the MS to elaborate and adopt a rare disease plan or strategy by the end of 2013. Europlan is an inclusive project, with 57 associated and collaborating partners - including clinicians, scientists, health authorities, and patient groups from 34 countries. The Europlan project created a toolbox designed to aid countries determine their priority areas and actions to include in a national plan. Some 15 individual EU countries hosted national conferences via the project. These conferences, designed to move forward the process of developing a national strategy for rare diseases, followed a format based on Europlan guidance documents. The final reports of these national conferences are available on the Eurordis website (www.eurordis.org).
a country with 21 autonomous regions is a priority Italy but the countrys organization presents a daunting challenge. Italy also reports a long time for orphan drug approvals to be processed. The Netherlands is a country with a solid general health plan, which could explain why the Minister of Health is not in favor of developing a plan specifically for rare diseases. Furthermore, the countrys Steering Committee for Orphan Drugs is to be shelved at the end of 2011. In Poland, the process of elaborating a plan has not yet began, but awareness is increasing. Poland needs to focus on all elements of rare disease strategizing not just the orphan drugs. Spain does have a plan, but it has neither a budget nor a timetable. The UK seems to be moving forward, thanks in large part to the steam of the Rare Disease UK and similar patientdriven efforts.
A challenging dynamic
With several plans existing only on paper, other countries such as Denmark and the Netherlands reporting a regression, and other MS lacking resources, the dream that each MS will have a specific strategy to care for its rare disease patients, and which includes cooperation between the EU countries to share resources, is a fragile one. This is a critical time for each stakeholder to continue acting as a catalyst to push change forward. The recent adoption of the Cross Border Health Care Directive increases the need for concerted effort, with each EU country identifying its pockets of expertise and making them known, within the context of acknowledging and respecting the individual dynamic of each country, particularly its size and resources. Analysis of the results of this first
Contd on page 48
The European dimension

At the final Europlan meeting, it was observed that one of the strongest elements of the Europlan project was its role in adding the European dimension to individual national strategies. This point is critical to the field of rare diseases, which relies on coordination and collaboration at the European and international levels. The recent Eurobarometer survey results demonstrate that there is support for European cooperation (www.orpha.net/actor/ EuropaNews/2011/110316.html#Edito). Catherine Berens (DG Research) adduced the E-Rare project (www.e-rare.eu/) as an effective strategy for the funding of collaborative research. A Round Table meeting reviewed some of the overall results of the Europlan project such as its role in harmonizing concepts and terminology between the MS and in helping to raise awareness at the MS level for key EU documents in the field of rare diseases and orphan drugs. During this session, the need for integrating the elements of the national rare disease plans into the national health care systems was discussed. The importance of mapping existing resources - which Orphanet, the pan-European information portal for rare diseases and orphan drugs, is doing was also evoked. Other elements identified include the need for inclusivity i.e., involving all the various stakeholders in the development of a national plan; the need for the national protocols for diagnostics and care of a disease to include the provisions for patient coverage for testing and care; and the healthcare pathways the multidisciplinary algorithms of care structured to support the implementation of clinical guidelines and protocols.
At the national level

Discussion of the status of particular countries was also raised. While Bulgaria has a concrete plan, accessing funding remains problematic, especially in the area of diagnostics. Croatia hopes to put forward a plan in 2012. Denmark is in a period of regression, illustrated by the countrys information center exclusively for rare diseases that has been extended to encompass all diseases. Greece has a plan on paper, but it is not yet legally recognized, and the country has no national committee to implement it. There are also significant problems with access to orphan drugs in Greece. Starting a process to develop a plan in
47
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LMI-09-11 134
EFCC CORNER
Strategic Framework for Quality Management and Accreditation at Medical Laboratories in Serbia
by Sanja Stankovic, Institute for Medical Biochemistry, University School of Pharmacy & Clinical Center of Serbia
n Serbia, accreditation is granted by the Accreditation Body of Serbia (ATS) funded by the government of the Republic of Serbia. Other organs of the ATS are the Management Board director and the Supervisory Board. ATS became an associate member of the international Laboratory accreditation cooperation-ILAC, and it is in the process of the European Cooperation for Accreditation (EA) peerevaluation that will grant official recognition of the certificates and reports issued by our laboratories at regional and international level by signing multilateral agreement-MLA with EA members. It makes accreditation a passport, which facilitates access to the EU and international markets. Except for those permanent employers, assessors and technical
experts could be appointed to the ATS to be included in the process of accreditation, doing assessment visits, evaluating the quality of work and writing reports with clearly documented evidence. A few years ago, another institution was responsible for the accreditation services in Serbia, when the Agency for Accreditation of health care Institutions of Serbia was funded. Establishment of the program for accreditation of health care institutions in Serbia began as a part of Serbia Health project of the Minister of Health of the Republic of Serbia and World Bank. This project has been tested in four pilot hospitals and sixteen primary health care centers, including medical laboratories based in these institutions.
Final Europlan Conference Takes Stock of Progress in National Strategies for Rare Diseases
Contd from page 47
Europlan project can help refine the second leg of the plan, which is being funded via the upcoming DG Sanco three-year joint action support to the implementation of national plans/strategies on rare diseases and related measures to implement Council Recommendation and Commission Communication on rare diseases. The second Europlan will continue to offer support and guidance to countries that have
delineated a strategy and will aid countries that have not developed a plan to move forward, taking into account the specifics of each country in terms of size, prioritization of measures and health care systems. There will also be an emphasis on the exchange of expertise between countries, as well as identifying outcome indicators that can be monitored. Twenty national conferences are being planned for the second Europlan.
Accreditation is voluntary in the Republic of Serbia. At this moment, only 3 medical laboratories are accredited according ISO 15189, and 17 according ISO 17025. The first is the Institute for Medical Biochemistry in Clinical Center of Serbia that in 2000 started working on the introduction of quality management systems according to ISO 9001 standard, in 2006, on accreditation based on ISO 17025, and in 2008, on ISO 15189. Prof. S. Stankovic explained all those different stages in medical laboratory accreditation in her country from her own experience and the formalizing of initial contacts with ATS, later on, through the application for obtaining accreditation, and self-assessment, preassessment visit, external assessment (evaluation by team of assessors), and accreditation decision which granted accreditation. Accreditations have to be renewed every 4 years. Finally, Prof. S. Stankovic concluded that those basic characteristics of accreditation were first, the prevailing sense of volunteerism, second, the strong tradition of self-regulation, and third, the reliance on evaluation techniques, and their primary concern for quality. But, what are the main benefits of accreditation? Accreditation provides prestige, excellence, accredited status, with the possibility of recognizing the strength and the weakness of the medical laboratory. It is clear now that "Accreditation is a journey, and not a destination. Bon voyage!"
48
INDUSTRY NEWS
Alere Inks Worldwide Marketing Rights for Spina Bifida Risk Assessment Test
OraSure Acquisition Expands Oral Fluid Diagnostics Range

raSure Technologies, Inc. (Bethlehem, PA, USA; www.orasure. com) will acquire privately held DNA Genotek Inc. (Ottawa, Canada; www.dnagenotek.com), a leading provider of oral fluid sample collection, stabilization, and preparation products for molecular diagnostic applications. The transaction valued at approximately US$53 million is anticipated to close in the third quarter of 2011. The acquisition of DNA Genotek will strengthen OraSures leadership in oral fluid diagnostics, by providing a complementary portfolio of products that enable easy and reliable collection, stabilization, transportation, and storage of high quality nucleic acid (DNA and RNA) samples. These samples can then be used for a wide range of diagnostic and research applications. The Oragene DNA sample collection kit is DNA Genotek's lead product, providing an all-in-one system for the collection, stabilization, transportation and purification of DNA from saliva. Genetic samples are collected using a simple, noninvasive method; collected samples may be transported and stored for extended periods at ambient temperatures.
lere (Waltham, MA, USA; www. alere.com) has received the licence for worldwide marketing rights to VitaPaths (Foster City CA, USA; www.vpgenetics.com) spina bifida risk assessment assay, which is expected to be commercially launched in 2012. In addition, Alere has licensed the right to develop with VitaPath additional product line extensions primarily focused in the area of fetal health. The terms of the transaction were not disclosed. The assay is a genetic test that identifies elevated risk in women of childbearing age for the common birth defect spina bifida, which can be prevented with high-dose folic acid under the care of a physician. Spina bifida is the most common
permanently disabling birth defect in the United States. Spina bifida occurs when the backbone and spinal canal do not close completely in the first month of pregnancy. VitaPath Genetics develops molecular assays to predict disorders that can be prevented or safely treated with vitamin-based therapeutics. VitaPaths discovery and clinical validation platform focuses on common and rare functional genetic variants that are associated with serious disease and can be remediated with minimal risk. Aleres global products and services, as well as its new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse, and womens health.
Increase in Elderly Population Drives IVD Market Growth

s Taiwan's elderly population increases the in vitro diagnostics (IVD) market is expected to grow at a stable compound annual growth rate of 6.1 per cent from 2010 to 2017. In a new analysis, the growth partnership company Frost & Sullivan (New York, NY, USA; www.frost. com) found that the market earned revenues of US$252 million in 2010 and expects this to reach $381 million in 2017. End users' growing willingness to use advanced tests and products will drive manufacturers to introduce constantly novel tests. Biotech participants will also be sustained by the continuous Government support to
standardize medical device and initiatives to develop the country into a healthcare hub. For example, the Government implemented the The Taiwan Diamond Plan for Biotechnology Development to encourage R&D, accumulate biotechnology venture capital (BVC), and aid start-up enterprises. However, the lack of clarity on reimbursement coverage for molecular tests could impede the market's growth. In addition, intellectual property (IP) issues and legal issues deter foreign companies from setting up their R&D centers in Taiwan. The success of local companies also depends on insurance coverage.
DNA Genotek products are used in clinical genetic testing, pharmacogenomics, personalized medicine, academic research, animal genetics, and livestock genetics markets. DNA Genotek is a leading provider of oral fluid collection devices to the directto-consumer personal genetics testing market. The company supplies products that provide substantial advantages over traditional methods of sampling such as blood or buccal swabs. OraSure Technologies is a leader in the development, manufacture, and distribution of oral fluid diagnostic devices and other technologies designed to diagnose critical medical conditions and diseases. Its innovative products include rapid tests for the detection of antibodies to Human Immunodeficiency virus (HIV) and Hepatitis C virus (HCV) at the point of care (POC) and testing solutions for detecting various drugs of abuse. OraSures products are sold globally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
49
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10th Czech National Congress of Clinical Biochemistry. September 25-27; Pilsen, Czech Republic; Web: www.sjezdcskb2011.cz 50th Annual ESPE Meeting European Society of Paediatric Endocrinology. Sept 2528; Glasgow, UK; Web: www.espe2011.org
OCTOBER 2011
12th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology. October 2-6; Stuttgart, Germany; Web: www. iatdmct2011.de Biotechnica 2011. October 11-13; Hannover, Germany; Web: www.biotechnica.de 12th International Congress of Human Genetics. October 11-15; Montreal, Quebec, Canada; Web: www.ichg2011.org Analytica Anacon India. October 12-14; Mumbai, India; Web: www.analyticaindia.com ASHG 2011 - Annual Meeting of the American Society of Human Genetics. October 13-15; Montreal, QC, Canada; e-mail: ashgmeetings@ashg.org; Web: www.ashg.org 67th Annual Meeting of the American Society for Reproductive Medicine. October 15-19; Orlando, FL, USA; www.asrm.org 37th Annual Meeting of the American Society for Histocompatibility and Immunogenetics (ASHI). October 17-21; New Orleans, LA, USA; e-mail: info@ashi-hla.org; Web: www.ashi-hla.org 26th WASPaLM World Association of Pathology and Laboratory Medicine. October 19-23; Las Vegas, NV, USA; Web: www. waspalm.org
SEPTEMBER 2011
RNAi and miRNA Europe. September 8-9; Munich, Germany; Web: www.selectbiosciences. com qPCR Europe. Sep 8-9; Munich, Germany; Web: www.selectbiosciences.com Epigenetics Europe September 8-9; Munich, Germany; Web: www.selectbiosciences.com CAP 2011 The Pathologists Meeting. September 11-14; Grapevine, TX, USA; Web: www.cap.org 7th European Course on Clinical Cytometry and 11th Euroconference on Clinical Cell Analysis. September 13-17; Dublin, Ireland; Web: www.cytometry2011.eu 19th ECDO Euroconference on Apoptosis European Cell Death Organization. Sep 1417; Stockholm, Sweden; Web: www.ecdo.eu 11th Analytica Latin America. September 20-22; Sao Paulo, Brazil; Web: www.analiticanet.com.br 14th Annual Meeting of the European Society for Clinical Virology. Sep 21-24; Funchal, Portugal; Web: www.escv.org BCLF 2011 - 19th Annual Meeting of the Balkan Clinical Laboratory Federation. September 21-23; Bucharest, Romania; Web: www.bclf.info 36th European Congress of Cytology. September 22-25; Istanbul, Turkey; Web: www.cytologyistanbul2011.com
NOVEMBER 2011
Annual Assembly of the Swiss Society of Clinical Chemistry & Tri-National Congress of Laboratory Medicine. November 2-4; Zurich, Switzerland Web: www.congress-info. ch/sscc2011/p1.html 58th Annual Scientific Meeting of the
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