LeukoStrat® CDx FLT3 Mutation Assay

Test Code

90574

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.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
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 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.