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Report Information from ProQuest

03 October 2015 06:53
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Table of contents
1. Vermillion, Inc.; American Journal of Obstetrics & Gynecology Publishes New Clinical Study on the
Relationship Between Imaging and OVA1(R) in Assessing Risk of Ovarian Cancer......................................

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Vermillion, Inc.; American Journal of Obstetrics &Gynecology Publishes New Clinical Study on the
Relationship Between Imaging and OVA1(R) in Assessing Risk of Ovarian Cancer
ProQuest document link
Abstract: Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs.
[Fred Ueland, M.D.] and Rachel Ware Miller. The findings are the third in a series of subset analyses of data
obtained from 1,100 ovarian mass surgery patients in two previous pivotal trials of OVA1 clinical performance,
conducted in 2007 and 2012. The authors compared the performance of each imaging method alone, to the
performance of OVA1 alone (for risk stratification), as well as in combination with OVA1. In addition, the authors
presented logistic regression models showing how menopausal status, high- or low-risk imaging and OVA1
score interact in the assessment of ovarian cancer risk. The researchers concluded that "serum biomarkers and
imaging are a complementary set of clinical tools and that when the [OVA1] score is further stratified by imaging
risk and menopausal status, there is a better understanding of the clinical risk of ovarian malignancy."
Full text: 2014 APR 5 (NewsRx) -- By a News Reporter-Staff News Editor at Cancer Law Weekly -- (Nasdaq:
VRML) -- A new study of OVA1(R) clinical performance, titled "The Effect of Ovarian Imaging on the Clinical
Interpretation of a Multivariate Index Assay," has been released as an online advance publication of The
American Journal of Obstetrics &Gynecology.[1] The study examines the relationship between two commonly
used imaging methods - ultrasound (US) and computed tomography (CT) - and the OVA1 test result, in
assessing the risk of ovarian cancer among patients planning surgery for an ovarian mass. OVA1 is an FDAcleared blood test that measures the levels of five proteins and then uses a proprietary algorithm and software
called OvaCalc(R) to calculate a single risk score.
"This new study advances our understanding of how OVA1 and imaging work together in the pre-surgical
assessment of ovarian cancer risk," said study co-author Fred Ueland, M.D., associate professor of gynecologic
oncology at the University of Kentucky's Markey Cancer Center. "This is important for two reasons. First, adding
OVA1 reduced the number of ovarian cancers missed with imaging alone, by 85 to 90 percent. Recent
publications have reinforced that the first surgery is an important opportunity to improve ovarian cancer survival
by ensuring that cancers are detected earlier and that they are operated on by the most experienced specialists.
Second, this study provides new evidence of how menopausal status, imaging and OVA1 score may
interrelate."
Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs. Fred Ueland
and Rachel Ware Miller. The findings are the third in a series of subset analyses of data obtained from 1,100
ovarian mass surgery patients in two previous pivotal trials of OVA1 clinical performance, conducted in 2007
and 2012. The authors compared the performance of each imaging method alone, to the performance of OVA1
alone (for risk stratification), as well as in combination with OVA1. In addition, the authors presented logistic
regression models showing how menopausal status, high- or low-risk imaging and OVA1 score interact in the
assessment of ovarian cancer risk. The researchers concluded that "serum biomarkers and imaging are a
complementary set of clinical tools and that when the [OVA1] score is further stratified by imaging risk and
menopausal status, there is a better understanding of the clinical risk of ovarian malignancy."
This latest study brings the number of full research articles on OVA1 clinical performance to a total of five peerreviewed publications. Together, these data provide strong, prospective clinical evidence that OVA1 improves
the pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients undergoing surgery for a
suspicious ovarian mass.
"The sensitivity of OVA1 is critical to the detection of ovarian malignancy, pre-surgical risk assessment and
determining whether a woman may benefit from consultation with a gynecologic oncologist prior to surgery,"
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said Donald Munroe, chief scientific officer and SVP of business development at Vermillion. "Vermillion is
committed to fully developing this clinical evidence, together with future studies on how OVA1 may impact the
efficiency and quality of care for women facing ovarian cancer, the deadliest of all gynecologic malignancies."
More than 22,000 women are diagnosed with ovarian cancer in the United States annually, and more than
12,000 die each year.[2] Leading medical associations, including the American College of Obstetrics and
Gynecology (ACOG), recommend that women with suspected ovarian cancer be referred to a gynecologic
oncologist for surgery for the best potential outcomes. However, only an estimated one-third of women who
have a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer.[3]
This publication, "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," is
also co-authored by Dr. Robert Bristow (UC Irvine, Calif.), Dr. Joseph Santoso (The West Clinic, Tenn.), Dr.
Zhen Zhang (Johns Hopkins Medical Institute) and Alan Smith (Applied Clinical Intelligence). It will be published
in print in the 2(nd) quarter of 2014 in the American Journal of Obstetrics &Gynecology.
Keywords for this news article include: Cancer, Surgery, Oncology, Vermillion Inc.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014,
NewsRx LLC
People: Fred Ueland, MD
Publication title: Cancer Law Weekly
First page: 166
Publication year: 2014
Publication date: Apr 5, 2014
Year: 2014
Publisher: NewsRx
Place of publication: Atlanta
Country of publication: United States
Publication subject: Medical Sciences--Oncology
ISSN: 15515281
Source type: Trade Journals
Language of publication: English
Document type: Expanded Reporting
ProQuest document ID: 1510129205
Document URL: http://search.proquest.com/docview/1510129205?accountid=25704
Copyright: Copyright 2014, Cancer Law Weekly via NewsRx.com
Last updated: 2014-03-26
Database: ProQuest Health Management

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