b'LeukoStrat CDx FLT3 MutationCDx TestingAssay - USAPredictive test for the efficacy of RYDAPT (midostaurin)and XOSPATA (gilteritinib fumarate) Intended Use The LeukoStrat CDx FLT3 Mutation Assay is used as an aidTest Name The TKD PCR product is further digested with a restriction The LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedin the selection of patients with AML for whom XOSPATALeukoStrat CDx FLT3 Mutation Assay enzyme. The ITD PCR products and the digested TKD in vitro diagnostic test designed to detect internal tandem(gilteritinib) treatment is being considered. PCR products are analyzed on a capillary electrophoresis duplications (ITD) and tyrosine kinase domain (TKD)The LeukoStrat CDx FLT3 Mutation Assay is to be performedAssay Type instrument. mutations D835 and I836 in the FLT3 gene in genomic DNAonly at Laboratory for Personalized Molecular MedicineFLT3 ITDs are detected by a change in the expectedextracted from mononuclear cells obtained from peripheral(LabPMM) LLC, a single laboratory site, located at 10222Capillary Electrophoresis size of a wild type fragment. An amplicon larger thanblood or bone marrow aspirates of patients diagnosed withBarnes Canyon Rd., Bldg. 1, San Diego, CA 92121. the wild type fragment indicates the presence of FLT3 ITD.acute myelogenous leukemia (AML). Method Description The TKD digestion pattern identifies loss of the normalThe LeukoStrat CDx FLT3 Mutation Assay is used as an aid gene sequences and ensures that digestion occurred. in the selection of patients with AML for whom RYDAPTThe LeukoStratCDx FLT3 Mutation Assay is designed to (midostaurin) treatment is being considered. detect ITD and TKD mutations in the FLT3 gene.Indications for TestingThe assay is performed on DNA isolated from mononuclearAt initial diagnosis of AMLcells obtained from peripheral blood or bone marrowAs an aid in the selection of patients with AML for whom aspirates of patients diagnosed with AML. RYDAPT (midostaurin) treatment is being considered.Primers targeting both in and around the juxtamembraneAs a tool to identify AML patients eligible for treatment region for ITD testing and kinase domain of the FLT3 genewith XOSPATA (gilteritinib fumarate). Mutations in the FLT3 gene are the most common mutations found in AML are used to amplify DNA extracted from a patient sample.12 Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable Interpretation TurnaroundSpecimen Requirements ShippingStorage Time Conditions Conditions3 Midostaurin was approved by the FDA 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 daysissued, indicating1 mL of bone marrow in sodiumfreeze.4 The LeukoStrat CDx FLT3 Mutation Assay is the first FDA approved (PMA# P160040) predictive testwhether the patient95% patient for the efficacy of midostaurin therapy in all AML patients, regardless of cytogeneticsis eligible forsamples areheparin tubes onlymidostaurin and/orreported within gilteritinib fumarate48 hours of 5 Gilteritinib fumarate was approved by the FDA for the treatment of adult patients with relapsed/treatment receiptrefractory FLT3mut+ AML 6 The LeukoStrat CDx FLT3 Mutation Assay is used as aid in the selection of AML patients for whom midostaurin or gilteritinib fumarate are being considered14 LabPMM Services Catalog 2020|15'