CLL COMPLETE

SM

Chronic Lymphocytic Leukemia (CLL) arises through clonal expansion of CD5+ B lymphocytes. Accurate prognostication for treatment options is highly desirable in CLL considering that it occurs almost exclusively in adults (median age at diagnosis is 65 years) and that patients display great clinical heterogeneity in the course of their disease. CLL CompleteSM integrates the latest prognostic molecular markers including proprietary testing to risk-stratify individual patients for disease progression, response to treatment, and overall prognosis.

Clinical Indications
Prognosis and clinical management of CLL/SLL.

List of CLL CompleteSM Tests

Tests can be ordered individually or based on the diagnosis under consideration, CGI will perform the comprehensive panel as determined necessary by a CGI hemopathologist and directors. MatBA-CLL/SLL Array CGH (CLIA and New York State licensed) Mature B-Cell neoplasms exhibit clonal genomic alterations that have diagnostic and prognostic significance. One such type of alteration is gain or loss of genomic loci, which in the current test, is assayed by array-comparative genomic hybridization (array CGH) permitting the simultaneous detection of gain and loss at multiple loci. Loci being assessed by MatBA -CLL/SLL are 2p, 3q, 8p, 8q, 11q (ATM), 12, 13q (RB1 & MIR15A/16.1), and 17p (TP53). IGHV Mutation Analysis Detection of hyper-mutation in the IGHV gene serves as an independent prognostic marker. Patients with the hyper-mutated IGHV gene exhibit a better overall survival than those with unmutated IGHV. Utilization of IGHV3-21 is associated with an unfavorable outcome. TP53 Mutation Analysis The presence of a TP53 mutation is associated with short survival and resistance to chemotherapy. NOTCH1 Mutation Analysis Mutational NOTCH1 activation in CLL diagnosis is an independent predictor of poor survival and a shorter time to progression. SF3B1 Mutation Analysis SF3B1 mutations are independent predictors that occur in 10-15% of CLL patients. They are indicative of shorter time to treatment, and a poorer overall survival.

Molecular Diagnostics
Cytogenetics

FDA-Approved FISH Probe Panel The FISH analysis provides high sensitivity information about key genomic alternations and prognostic markers, such as the loss of 17p (TP53), 11q (ATM), 13q, and 6q, along with the gain of chromosome 12. The translocation of chromosome 11 and 14 is also evaluated to rule out Mantle Cell Lymphoma. Karyotyping Karyotyping enables genome-wide detection of aberrations at low resolution that have a diagnostic and prognostic significance for CLL. CD38 CD38 has been identified as an independent prognostic marker and high expression is associated with an unfavorable clinical course. ZAP-70 ZAP-70 is an independent prognostic marker of CLL that is used as a surrogate marker for IGHV mutation analysis. A high level of the ZAP-70 protein correlates with an aggressive form of the disease.
201 Route 17 North Rutherford NJ 07070 Office 888.334.4988 Fax 201.528.9201 www.cancergenetics.com
041013

Flow Cytometry

Specimen Requirements
Test MatBACLL/SLL Sample
Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate Peripheral blood or bone marrow aspirate

Tube
Lavender top EDTA tube

Quantity

Shipping
Room temperature

Turn Around Time

2-3 ml

10-14 business days

Molecular Diagnostics

IGHV Mutation Analysis TP53 Mutation Analysis NOTCH1 Mutation Analysis SF3B1 Mutation Analysis

Lavender top EDTA tube

2-3 ml

Room temperature

7-10 business days

Lavender top EDTA tube

2-3 ml

Room temperature

7-10 business days

Lavender top EDTA tube

2-3 ml

Room temperature

5-7 business days

Lavender top EDTA tube

2-3 ml

Room temperature

5-7 business days

Cytogenetics

G-banding

Green top NaHeparin tube

3-5 ml

Room temperature

5-7 business days

FISH

Green top NaHeparin tube Lavender top EDTA tube or Green top NaHeparin tube Lavender top EDTA tube or Green top NaHeparin tube Lavender top EDTA tube and Green top NaHeparin tube

3-5 ml

Room temperature

3-5 business days

Flow Cytometry

CD38

3-5 ml

Room temperature

1-2 business days

ZAP-70

3-5 ml

Room temperature

1-2 business days

CLL CompleteSM Panel

5-7 ml 5-7 ml

Room temperature

10-14 business days

Licensure CAP (Laboratory # : 7191582, AU-ID: 1434060), CLIA (Certificate # : 31D1038733), New Jersey (CLIS ID # : 0002299), New York State (PFI: 8192), Pennsylvania (031978), Florida (800018142), Maryland (1395).

201 Route 17 North Rutherford NJ 07070 Office 888.334.4988 Fax 201.528.9201 www.cancergenetics.com
041013