7/30/2019 CLL Complete 041013

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201 Route 17 North Rutherford NJ 07070 Office 888.334.4988 Fax 201.528.9201

www.cancergenetics.com041013

Chronic Lymphocytic Leukemia (CLL) arises through clonal expansion of CD5+ B lymphocytes. Accurateprognostication for treatment options is highly desirable in CLL considering that it occurs almost exclusivelyin 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 includingproprietary testing to risk-stratify individual patients for disease progression, response to treatment, andoverall prognosis.

Clinical IndicationsPrognosis and clinical management of CLL/SLL.

List of CLL CompleteSM TestsTests can be ordered individually or based on the diagnosis under consideration, CGI will perform thecomprehensive 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 prognosticsignificance. One such type of alteration is gain or loss of genomic loci, which in the current test, isassayed by array-comparative genomic hybridization (array CGH) permitting the simultaneousdetection 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 un-mutated IGHV. Utilization of IGHV3-21 is associated with an unfavorable outcome.TP53Mutation Analysis

The presence of a TP53 mutation is associated with short survival and resistance tochemotherapy.

NOTCH1Mutation AnalysisMutational NOTCH1 activation in CLL diagnosis is an independent predictor of poor survival and ashorter time to progression.SF3B1Mutation Analysis

SF3B1 mutations are independent predictors that occur in 10-15% of CLL patients. They areindicative of shorter time to treatment, and a poorer overall survival.

FDA-Approved FISH Probe PanelThe FISH analysis provides high sensitivity information about key genomic alternations andprognostic markers, such as the loss of 17p (TP53), 11q (ATM), 13q, and 6q, along with the gain ofchromosome 12. The translocation of chromosome 11 and 14 is also evaluated to rule out MantleCell Lymphoma.Karyotyping

Karyotyping enables genome-wide detection of aberrations at low resolution that have a diagnosticand prognostic significance for CLL.

CD38

CD38 has been identified as an independent prognostic marker and high expression is associatedwith 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.

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CLLCOMPLETESM

7/30/2019 CLL Complete 041013

2/2

201 Route 17 North Rutherford NJ 07070 Office 888.334.4988 Fax 201.528.9201

www.cancergenetics.com041013

Specimen Requirements

Test Sample Tube Quantity Shipping Turn Around Time

MatBA-

CLL/SLL

Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube

2-3 mlRoomtemperature

10-14 business days

IGHV

Mutation

Analysis

Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube

2-3 mlRoomtemperature

7-10 business days

TP53

Mutation

Analysis

Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube

2-3 mlRoomtemperature

7-10 business days

NOTCH1

MutationAnalysis

Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube

2-3 mlRoomtemperature

5-7 business days

SF3B1

MutationAnalysis

Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube

2-3 mlRoomtemperature

5-7 business days

G-bandingPeripheral bloodor bone marrowaspirate

Green topNaHeparin tube

3-5 mlRoomtemperature

5-7 business days

FISHPeripheral bloodor bone marrowaspirate

Green topNaHeparin tube

3-5 mlRoomtemperature

3-5 business days

CD38Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube orGreen topNaHeparin tube

3-5 mlRoomtemperature

1-2 business days

ZAP-70Peripheral bloodor bone marrowaspirate

Lavender topEDTA tube orGreen topNaHeparin tube

3-5 mlRoomtemperature

1-2 business days

CLL Complete

SM

Panel

Peripheral blood

or bone marrow

aspirate

Lavender top

EDTA tube andGreen top

NaHeparin tube

5-7 ml

5-7 ml

Roomtemperature

10-14 business days

LicensureCAP (Laboratory #: 7191582, AU-ID: 1434060), CLIA (Certificate #: 31D1038733), New Jersey (CLIS ID #:

0002299), New York State (PFI: 8192), Pennsylvania (031978), Florida (800018142), Maryland (1395).

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