b'LeukoStrat CDx FLT3 Mutation CDx TestingAssay(CE-marked)Predictive test for the efficacy of RYDAPT (midostaurin)and XOSPATA (gilteritinib fumarate)Intended Use In regions where gilteritinib fumarate is available, the Test Name PCR products are analyzed on a capillary electrophoresis LeukoStrat CDx FLT3 Mutation Assay is used as an aid ininstrument.The LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedthe assessment of patients with AML for whom XOSPATALeukoStrat CDx FLT3 Mutation Assayin vitro diagnostic test designed to detect internal tandem(gilteritinib fumarate) treatment is being considered.FLT3 ITDs are detected by a change in the expectedduplications (ITD) and tyrosine kinase domain (TKD)Assay Type size of a wild type fragment. An amplicon larger thanmutations D835 and I836 in the FLT3 gene in genomic DNAthe wild type fragment indicates the presence of FLT3 ITD.extracted from mononuclear cells obtained from peripheralCapillary Electrophoresis The TKD digestion pattern identifies loss of the normalblood or bone marrow aspirates of patients diagnosed withgene sequences and ensures that digestion occurred.acute myelogenous leukemia (AML). Method DescriptionIn regions where midostaurin is available, theLeukoStratThe LeukoStrat CDx FLT3 Mutation Assay is designed toIndications for TestingCDx FLT3 Mutation Assay is used as an aid in thedetect ITD and TKD mutations in the FLT3 gene.In regions where midostaurin is available, the LeukoStrat assessment of patients with AML for whom RYDAPTCDx FLT3 mutation assay is used as an aid in the (midostaurin) treatment is being considered.The assay is performed on DNA isolated from mononuclearassessment of AML patients for whom midostaurin cells obtained from peripheral blood or bone marrowtreatment is being considered.aspirates of patients diagnosed with AML. In regions where gilteritinib fumarate is available, the 1 Mutations in the FLT3 gene are the most common mutations found in AML Primers targeting both in and around the juxtamembraneLeukoStrat CDx FLT3 mutation assay is used as an aid region for ITD testing and kinase domain of the FLT3 genein the assessment of AML patients for whom gilteritinib are used to amplify DNA extracted from a patient sample.fumarate treatment is being considered. 2 Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable The TKD PCR product is further digested with a restriction enzyme. The ITD PCR products and the digested TKD 3 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 consideredInterpretation TurnaroundSpecimen Requirements ShippingStorage Time Conditions Conditions4 Midostaurin was approved by the Swissmedic and European Commission for the treatment of adult patients with newly diagnosed AML who are FLT3 mutation positive An interpretive2 to 3 3 mL of peripheral blood in2C to 8C up to2C to 8C up report will bebusiness dayssodium heparin tubes only 72 hours; do notto 7 days5 Gilteritinib fumarate was approved by the European Commission for the treatment of relapsed/issued indicating1 mL of bone marrow in sodiumfreeze.the absence or95% of patient refractory FLT3mut+ AML presence of a FLT3samples areheparin tubes onlymutation and itsreported within corresponding48 hours of signal ratio.receiptThe report will further indicate whether the patient is eligible for a therapy with midostaurin or gilteritinib hydrochloride.16 LabPMM Services Catalog 2020|17'