b'CDxLeukoStrat CDx FLT3 Mutation EUROPEAN COMMISSION &TestingAssay(CE-marked) SWISSMEDIC APPROVEDPREDICTIVE TEST FOR THE EFFICACY OF RYDAPT (MIDOSTAURIN) AND XOSPATA (GILTERITINIB FUMARATE)Test NameIntended Use LeukoStrat CDx FLT3 Mutation Assay FLT3 ITDs are detected by a change in the expectedsize of a wild type fragment. An amplicon larger thanIn regions where gilteritinib fumarate is available, the the wild type fragment indicates the presence of FLT3 ITD.The LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedLeukoStrat CDx FLT3 Mutation Assay is used as an aid inAssay Type The TKD digestion pattern identifies loss of the normalin vitro diagnostic test designed to detect internal tandemthe assessment of patients with AML for whom XOSPATAgene sequences and ensures that digestion occurred.duplications (ITD) and tyrosine kinase domain (TKD)(gilteritinib fumarate) treatment is being considered.Capillary Electrophoresismutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheralMethod Description Indications for Testingblood or bone marrow aspirates of patients diagnosed withAt initial diagnosis or relapse of AMLacute myelogenous leukemia (AML). The LeukoStrat CDx FLT3 Mutation Assay is designed toIn regions where midostaurin is available, the LeukoStratdetect ITD and TKD mutations in the FLT3 gene.CDx FLT3 mutation assay is used as an aid in the In regions where midostaurin is available, theLeukoStratCDx FLT3 Mutation Assay is used as an aid in theThe assay is performed on DNA isolated from mononuclearassessment of AML patients for whom midostaurin assessment of patients with AML for whom RYDAPTcells obtained from peripheral blood or bone marrowtreatment is being considered.(midostaurin) treatment is being considered.aspirates of patients diagnosed with AML.In regions where gilteritinib fumarate is available, the 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. The TKD PCR product is further digested with a restriction 1 Mutations in the FLT3 gene are the most common mutations found in AML enzyme. The ITD PCR products and the digested TKD PCR products are analyzed on a capillary electrophoresis 2 Presence of a FLT3 activation mutation in patients with AML may be prognostic and clinically actionable.instrument. Interpretation TurnaroundSpecimen Requirements ShippingSpecimen 3 NCCN, ELN and CAP Guidelines recommend FLT3 testing to inform patient treatment decisions. Time Conditions StabilityAn interpretive2 to 3 Recommended Specimen Volume2C to 8C up to2C to 8C up 4 The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of AML patients for whomreport will bebusiness days(Preservative) 72 hours; do notto 7 daysmidostaurin and/or gilteritinib treatment is being considered issued indicating2 mL of peripheral blood infreeze.the absence or95% of patientSodium Heparin or EDTApresence of a FLT3samples are 5 Midostaurin was approved by the Swissmedic and European Commission for the treatment of adultmutation and itsreported within0.5mL of bone marrow in patients with newly diagnosed AML who are FLT3 mutation positive corresponding48 hours ofSodium Heparin or EDTAsignal ratio.receipt Minimum Specimen Volume The report will(Preservative)6 Gilteritinib fumarate was approved by the European Commission for the treatment of relapsed/further indicate refractory FLT3mut+ AML whether the1mL of peripheral blood in patient is eligibleSodium Heparin or EDTAfor a therapy0.25 mL of bone marrow in with midostaurinSodium Heparin or EDTAor gilteritinib hydrochloride.14 LabPMM Services Catalog 2021|15'