Post on 14-Apr-2018
7/30/2019 CLL Complete 041013
1/2
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.
Flow
Cytometry
Cy
togenetics
Mol
ecularDiagnostics
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).
Flow
Cytometry
Cytog
enetics
Molecula
rDiagnostics