Hematologic Diseases

Cytogenetic abnormalities commonly associated with chronic lymphocytic leukemia (CLL) are detected by fluorescence in situ hybridization (FISH). Probes for IGH/CCND1 t(11;14), ATM (11q22.3), Cen 12 (+12), 13q (13q-/-13), TP53 (17p13.1) are included in the CLL FISH Profile (Enriched). B-cells are enriched from patient’s specimen using immunomagnetic enrichment technology with CD19/CD20 antibodies.

disease state indication(s)
Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL)

clinical use
The CLL FISH Profile (Enriched) detects cytogenetic abnormalities prognostically significant in chronic lymphocytic leukemia (CLL). Favorable cytogenetic abnormalities include del(13q) (as a sole abnormality), while unfavorable cytogenetic abnormalities include del(17p) and del(11q). Trisomy 12 is associated with an intermediate prognosis. The t(11;14) is characteristic of mantle cell lymphoma, and can help differentiate mantle cell lymphoma from atypical CLL. FISH analysis on specimens enriched for B-cells can enhance the ability to detect abnormalities, particularly in cases with a low percentage of monoclonal B-cells.

methodology/product platform
Fluorescence in situ hybridization (FISH)

specimen type and requirements
Peripheral blood: 5-6 mL in sodium heparin (green-top) tube.
Bone marrow: 2-3 mL in sodium heparin (green-top) tube.
Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability). Preferred transport in equal parts RPMI.
Lymphoid tissue: Transport in RPMI.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
DO NOT FREEZE.

Probe Prioritization: If samples are insufficient to complete the whole FISH panel, Genoptix will prioritize testing in the following order: TP53, ATM, IGH/CCND1, 13q, and Cen 12, unless directed otherwise by the client.

turnaround time
Tech-only (TC): 3 days
Global (TC & PC): 5 days

cpt code(s)
88368 (x1)
88369 (x2)
88377 (x2)
88112-TC (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC) or Tech-only (TC)