b'CDxLeukoStrat CDx FLT3 MutationFDA APPROVED TestingAssay - USAPREDICTIVE TEST FOR THE EFFICACY OF RYDAPT (MIDOSTAURIN) AND XOSPATA (GILTERITINIB FUMARATE)Test Name The TKD PCR product is further digested with a restriction Intended Use LeukoStrat CDx FLT3 Mutation Assay enzyme. The ITD PCR products and the digested TKD PCR products are analyzed on a capillary electrophoresis The LeukoStrat CDx FLT3 Mutation Assay is a PCR-basedThe LeukoStrat CDx FLT3 Mutation Assay is used as an aidinstrument. in vitro diagnostic test designed to detect internal tandemin the assessment of patients with AML for whom XOSPATAAssay Typeduplication (ITD) and tyrosine kinase domain (TKD)(gilteritinib) treatment is being considered. FLT3 ITDs are detected by a change in the expectedmutations D835 and I836 in the FLT3 gene in genomic DNACapillary Electrophoresis size of a wild type fragment. An amplicon larger thanextracted from mononuclear cells obtained from peripheralThe test is for use on the 3500xL Dx Genetic Analyzer. the wild type fragment indicates the presence of FLT3 ITD.blood or bone marrow aspirates of patients diagnosed withMethod Description The TKD digestion pattern identifies loss of the normalacute myelogenous leukemia (AML). gene sequences and ensures that digestion occurred. The LeukoStrat CDx FLT3 Mutation Assay is designed to The LeukoStrat CDx FLT3 Mutation Assay is used as an aiddetect ITD and TKD mutations in the FLT3 gene. in the assessment of patients with AML for whom RYDAPTIndications for Testing(midostaurin) treatment is being considered. The assay is performed on DNA isolated from mononuclearAt initial diagnosis or relapse of AMLcells obtained from peripheral blood or bone marrowAs an aid in the assessment of patients with AML for aspirates of patients diagnosed with AML. whom RYDAPT (midostaurin) treatment is being Primers targeting both in and around the juxtamembraneconsidered.region for ITD testing and kinase domain of the FLT3 geneAs a tool to identify AML patients eligible for treatment 1 Mutations in the FLT3 gene are the most common mutations found in AML are used to amplify DNA extracted from a patient sample. with XOSPATA (gilteritinib fumarate).2 Presence of a FLT3 activation mutation in patients with AML may be prognostic and clinically actionable. Interpretation TurnaroundSpecimen Requirements ShippingSpecimen Time Conditions Stability3 The LeukoStrat CDx FLT3 Mutation Assay is used as aid in the selection of AML patients for whom midostaurin or gilteritinib fumarate are being consideredAn interpretive2 to 3 Recommended Specimen Volume2C to 8C up to2C to 8C up report will bebusiness days(Preservative) 72 hours; do notto 7 days4 issued, indicating2 mL of peripheral blood infreeze.NCCN, ELN and CAP Guidelines recommend FLT3 testing to inform patient treatment decisions.whether the patient95% patientSodium Heparin or EDTAis eligible forsamples are 5 Gilteritinib fumarate was approved by the FDA for the treatment of adult patients with relapsed/midostaurin and/orreported within0.5mL of bone marrow in refractory FLT3mut+ AMLgilteritinib fumarate48 hours ofSodium Heparin or EDTAtreatment receipt Minimum Specimen Volume (Preservative)6 Midostaurin was approved by the FDA for the treatment of adult patients with newly diagnosed AML1mL of peripheral blood in who are FLT3 mutation positiveSodium Heparin or EDTA0.25 mL of bone marrow in Sodium Heparin or EDTA7 First-to-market, this CDx is FDA approved (PMA#P160040) as a predictive test for the efficacy of midostaurin therapy in all AML patients, regardless of cytogenetics.12 LabPMM Services Catalog 2021|13'