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LeukoStrat® CDx FLT3 Mutation Assay
Test Code90574
CPT Codes
0023U
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 with 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.
Submit blood and bone marrow samples with 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 Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Refrigerated: 7 days
Frozen: Unacceptable
Methodology
Polymerase Chain Reaction (PCR)
FDA Status
This test was developed and its performance characteristics determined by Invivoscribe, Inc. It has been approved by the U.S. Food and Drug Administration for use in the aid of prescribing midostaurin or gilteritinib (PMA# P160040). The Laboratory for Personalized Molecular Medicine performs the assay in accordance with the instructions for use provided by Invivoscribe, Inc.
*FLT3 Mutation Testing is performed pursuant to patents licensed from Takara Bio of Otsu, Japan.
Setup Schedule
Set up: Mon-Sat; Report available: 2-4 days
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).
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
LabPMM LLC
10222 Barnes Canyon Rd
San Diego, CA 92121