LeukoStrat® CDx FLT3 Mutation Assay

Test Code
90574


CPT Codes
81245, 81246

Preferred Specimen
2 mL whole blood collected in a sodium heparin (green-top) tube or EDTA (lavender-top) tube


Minimum Volume
1 mL whole blood • 0.25 mL bone marrow


Other Acceptable Specimens
0.5 mL bone marrow collected in a sodium heparin (green-top) tube or EDTA (lavender-top) tube


Instructions
Include patient's date of birth and specimen source on test request form and specimen container.
Submit blood and bone marrow samples within 7 days of collection. Primary samples received after 7 days of collection will be run with a disclaimer, but if the sample is QNS, the lab will charge for testing. Primary samples that are older than 14 days will not be tested.

Vendor does not accept samples Saturday, Sunday or holidays.


Transport Container
Sodium heparin (green-top) tube


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable


Methodology
Polymerase Chain Reaction (PCR)

Setup Schedule
Mon-sat


Reference Range
See Laboratory Report


Clinical Significance
The fms related tyrosine kinase 3 (FLT3) is one of the most commonly mutated genes in acute myeloid leukemia (AML), occurring in approximately 30% of patients at the time of diagnosis. Although generally associated with normal cytogenetics where patients have standard risk of relapse, FLT3 mutations have also been identified in sub-groups of patients with chromosomal abnormalities that are associated with high risk of disease relapse.
The LeukoStrat CDx FLT3 Mutation Assay is an IVD companion diagnostic to aid in the selection of acute myeloid leukemia (AML) patients eligible for treatment with midostaurin (US, EU) or gilteritinib fumarate (Japan, US, EU), or quizartinib hydrochloride (Japan).


Performing Laboratory
Laboratory for Personalized Molecular Medicine
10222 Barnes Canyon Road
San Diego, CA 92121



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.