Hematologic Diseases

Reverse transcriptase polymerase chain reaction (RT-PCR) for quantitative detection of t(15;17) PML-RARA, a recurrent genetic abnormality found in acute promyelocytic leukemia (APL). This RNA-based test detects all three gene fusion patterns: type A (short, S-form, bcr-3), type B (long, L-form, bcr-1), and type B variant (variable, V-form, bcr-2).

disease state indication(s)
Acute myeloid leukemia (AML), acute promyelocytic leukemia (APL)

clinical use
The t(15;17) translocation resulting in the PML-RARA fusion gene is the hallmark finding of acute promyelocytic leukemia (APL). This test is designed to detect the t(15;17) PML-RARA, and can be used to monitor minimal residual disease in APL

methodology/product platform
Polymerase chain reaction (PCR)

specimen type and requirements
Peripheral blood: 2-3 mL in EDTA (purple-top) tube. Bone marrow: 2-3 mL in EDTA (purple-top) tube. Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE.Amplicon-based, next-generation sequencing (NGS)

turnaround time
Global (TC & PC): 7-10 days

cpt code(s)
81315 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)