Hematologic Diseases

Cytogenetic abnormalities commonly associated with chronic myelogenous leukemia (CML) and CML in transformation are detected by fluorescence in situ hybridization (FISH). Probes for Cen 8 (+8), BCR/ABL1-ASS1 t(9;22), RARA (17q21.2)/(iso17q) are included in the CML FISH Profile.

disease state indication(s)
Chronic myelogenous leukemia (CML)

clinical use
The CML FISH Profile detects the t(9;22) BCR-ABL1 fusion gene, which is the hallmark finding in chronic myelogenous leukemia (CML), as well as additional cytogenetic abnormalities commonly associated with transformation.

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.
FFPE tissue: no decalcification (except for centromere as well as locus specific FISH probes)
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: BCR/ABL1-ASS1 t(9;22), Cen 8, and RARA/(iso17q), unless directed otherwise by the client.

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

cpt code(s)
88368 (x1)
88369 (x1)
88377 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

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