b'CDxEUROPEAN COMMISSION &TestingSWISSMEDIC APPROVEDTest NameLeukoStrat CDx FLT3 Mutation Assay FLT3 ITDs are detected by a change in the expectedsize of a wild type fragment. An amplicon larger thanthe wild type fragment indicates the presence of FLT3 ITD.Assay Type The TKD digestion pattern identifies loss of the normalgene sequences and ensures that digestion occurred.Capillary ElectrophoresisMethod Description Indications for TestingAt initial diagnosis or relapse of AMLThe LeukoStrat CDx FLT3 Mutation Assay is designed toIn regions where midostaurin is available, the LeukoStrat detect ITD and TKD mutations in the FLT3 gene.CDx FLT3 mutation assay is used as an aid in the 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 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 enzyme. The ITD PCR products and the digested TKD PCR products are analyzed on a capillary electrophoresis instrument.Interpretation TurnaroundSpecimen Requirements ShippingSpecimen Time Conditions StabilityAn interpretive2 to 3 Recommended Specimen Volume2C to 8C up to2C to 8C up report will bebusiness days(Preservative) 72 hours; do notto 7 daysissued indicating2 mL of peripheral blood infreeze.the absence or95% of patientSodium Heparin or EDTApresence of a FLT3samples are mutation and itsreported within0.5mL of bone marrow in corresponding48 hours ofSodium Heparin or EDTAsignal ratio.receipt Minimum Specimen Volume The report will(Preservative)further indicate1mL of peripheral blood in whether theSodium Heparin or EDTApatient is eligible for a therapy0.25 mL of bone marrow in with midostaurinSodium Heparin or EDTAor gilteritinib hydrochloride.LabPMM Services Catalog 2021|15'