LeukoStrat CDx FLT3 Mutation Assay - Acquired genetic alteration IVDs

Intended purpose

The LeukoStrat CDx FLT3 Mutation Assay is an in vitro diagnostic test intended for the qualitative detection of FLT3 internal tandem duplication (ITD) mutations and FLT3 tyrosine kinase domain (TKD) mutations D835 and I836 in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). The assay is indicated as an aid in assessment of patients with AML for whom treatment with XOSPATA® (gilteritinib fumarate) is being considered.

Functional description

A PCR‑based companion diagnostic that detects FLT3‑ITD and FLT3‑TKD mutations in AML patients.