b'LeukoStrat CDx FLT3 Mutation Assay - JapanPREDICTIVE TEST FOR THE EFFICACY OF XOSPATA (GILTERITINIB FUMARATE)AND VANFLYTA TM(QUIZARTINIB HYDROCHLORIDE) Intended UseThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-based,The 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 Gilteritinib duplication (ITD) mutations and tyrosine kinase domainFumarate treatment is being considered. (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained fromThe LeukoStrat CDx FLT3 Mutation Assay is used as an peripheral blood or bone marrow aspirates of patientsaid in the assessment of patients with AML for whom diagnosed with acute myelogenous leukemia.Quizartinib Hydrochloride 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 the first PMDA approved test for assessment of AML patients eligible for treatment with gilteritinib fumarate or quizartinib hydrochloride 4 Gilteritinib fumarate received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapse or refractory AML in Japan5 Quizartinib hydrochloride is MHLW/PMDA approved for the treatment of relapsed/ refractoryFLT3-ITD +AML16'