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FDA-approved companion diagnostic

LeukoStrat CDx FLT3 Mutation Assay

PCR-based assay that detects FLT3-ITD and TKD (D835/I836) mutations in AML patient samples to determine FLT3 mutation status and support use of FLT3-targeted therapies.

IVD-developed CDxMethod: PCRSpecimen: Whole blood, Bone marrowBiomarker: FLT3
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About this test

FDA approval details
PMA number
P160040
Supplements
S002, S011
Manufacturer
Invivoscribe Technologies, Inc.
Approval date
April 28, 2017
Test specifications
Methodology
PCR
Specimen
Whole blood, Bone marrow
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
FLT3
What this test is

LeukoStrat CDx FLT3 Mutation Assay is an FDA-approved, PCR-based fragment analysis test that qualitatively detects tandem duplications (ITD) in the juxtamembrane domain and D835/I836 kinase domain mutations in the FLT3 gene. Using DNA from peripheral blood or bone marrow of patients with acute myeloid leukemia, it determines FLT3 mutation status to support selection of FLT3-directed therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Acute Myeloid Leukemia (AML)FLT3 (ITD/TKD)ITD mutations and TKD mutations D835 and I836RYDAPT, VANFLYTA, XOSPATA

IVD Manufacturer

Invivoscribe Technologies, Inc.

Invivoscribe® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.

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CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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