Hematologic Diseases

Detects the FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, which are commonly found in acute myeloid leukemia (AML). FLT3 ITD and TKD regions are analyzed by polymerase chain reaction (PCR) and fluorescent fragment size analysis. The signal ratio of the FLT3 ITD region comparing the signal intensity of the mutation to the wild-type is reported in positive cases

disease state indication(s)
Acute myeloid leukemia (AML)

clinical use
FLT3 ITD mutations are associated with an unfavorable risk status in cytogenetically normal acute myeloid leukemia (AML). There is controversy as to whether FLT3 TKD mutations carry an equally unfavorable prognosis. Detection of the FLT3 ITD or TKD mutation is associated with an increased likelihood of repsonse to FLT3 inhibitors.

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.

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

cpt code(s)
81245 (x1) for ITD
81246 (x1) for TKD

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)