TEST:

LeukoStrat® CDx FLT3 Mutation Assay

The LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). It is used as an aid in the selection of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered. The LeukoStrat® CDx FLT3 Mutation Assay is to be performed only at Laboratory for Personalized Molecular Medicine (LabPMM) LLC. As the companion diagnostic to midostaurin (US, EU, Switzerland, Australia), gilteritinib fumarate (US, JP, EU), and quizartinib hydrochloride (JP), the LeukoStrat CDx is the only globally standardized FLT3 mutation test validated to meet international regulatory standards for detection of genetic mutations in the FLT3 gene.