b'LeukoStrat CDx FLT3 Mutation Assay - USAPREDICTIVE TEST FOR THE EFFICACY OF RYDAPT (MIDOSTAURIN) AND XOSPATA (GILTERITINIB FUMARATE) Intended Use The LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedThe LeukoStrat CDx FLT3 Mutation Assay is used as an aid in vitro diagnostic test designed to detect internal tandemin the assessment of patients with AML for whom XOSPATA duplication (ITD) and tyrosine kinase domain (TKD)(gilteritinib) treatment is being considered.mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheralThe test is for use on the 3500xL Dx Genetic Analyzer.blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT (midostaurin) treatment is being considered.1 Mutations in the FLT3 gene are the most common mutations found in AML2 Presence of a FLT3 activation mutation in patients with AML may be prognostic and clinically actionable. 3 The LeukoStrat CDx FLT3 Mutation Assay is used as aid in the selection of AML patients for whom midostaurin or gilteritinib fumarate are being considered4NCCN, ELN and CAP Guidelines recommend FLT3 testing to inform patient treatment decisions.5 Gilteritinib fumarate was approved by the FDA for the treatment of adult patients with relapsed/ refractory FLT3mut+ AML 6 Midostaurin was approved by the FDA for the treatment of adult patients with newly diagnosed AML who are FLT3 mutation positive 7 First-to-market, this CDx is FDA approved (PMA#P160040) as a predictive test for the efficacy of midostaurin therapy in all AML patients, regardless of cytogenetics.12'