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CLL Complete 041013
CLL Complete 041013
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.
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
2-3 ml
Molecular Diagnostics
IGHV Mutation Analysis TP53 Mutation Analysis NOTCH1 Mutation Analysis SF3B1 Mutation Analysis
2-3 ml
Room temperature
2-3 ml
Room temperature
2-3 ml
Room temperature
2-3 ml
Room temperature
Cytogenetics
G-banding
3-5 ml
Room temperature
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
Flow Cytometry
CD38
3-5 ml
Room temperature
ZAP-70
3-5 ml
Room temperature
5-7 ml 5-7 ml
Room temperature
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