b'LeukoStrat CDx FLT3 MutationAssay(CE-marked)PREDICTIVE TEST FOR THE EFFICACY OF RYDAPT (MIDOSTAURIN) AND XOSPATA (GILTERITINIB FUMARATE)Intended UseIn regions where gilteritinib fumarate is available, theThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedLeukoStrat CDx FLT3 Mutation Assay is used as an aid in in vitro diagnostic test designed to detect internal tandemthe assessment of patients with AML for whom XOSPATA duplications (ITD) and tyrosine kinase domain (TKD)(gilteritinib fumarate) treatment is being considered. 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).In regions where midostaurin is available, theLeukoStrat 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 NCCN, ELN and CAP Guidelines recommend FLT3 testing to inform patient treatment decisions.4 The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of AML patients for whom midostaurin and/or gilteritinib treatment is being considered5 Midostaurin was approved by the Swissmedic and European Commission for the treatment of adult patients with newly diagnosed AML who are FLT3 mutation positive6 Gilteritinib fumarate was approved by the European Commission for the treatment of relapsed/ refractory FLT3mut+ AML14'