b'Gel & Capillary | IVD Assays CDx FLT3 Mutation Assay (IVD)FDA Approved Companion Diagnostic InVitro Diagnostic Kit|PN: K4120361 FDA Approved Assay Available in USACDx FLT3 Mutation AssayFDA approved assay for assessment of acute myeloid leukemia (AML) patients eligible for treatment with RYDAPT (midostaurin) or XOSPATA (gilteritinib fumarate), now available as US distributed kit.This FLT3 companion diagnostic includes reagents along with software that identies ITD and TKD mutations, generates mutant/wildtype signal ratios, and predicts response to gilteritinib and midostaurin.Clinical Signicance of FLT3 Mutation Status: Each year approximately 21,000 patients in the United States are diagnosed with AML. Of those diagnosed with AML, ~1 out of 3 are expected to have presence of FLT3 mutations, (FLT3mut+). Since FLT3mut+ AML is clinically actionable, stratication of AML patients by testing for FLT3 mutation status has become a standard of care.Intended UseThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitroMethod Descriptiondiagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836ITD Mutations of FLT3 in the FLT3 gene in genomic DNA extracted from mononuclear cellsThe LeukoStrat CDx FLT3 Mutation Assay uses fluorescently labeled obtained from peripheral blood or bone marrow aspirates of patientsprimers that are in and around the JM region. Wild-type FLT3 alleles diagnosed with acute myelogenous leukemia (AML). will amplify and produce a product at 3271 bp as measured by this The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in theassay, while alleles that contain ITD mutations will produce a product assessment of patients with AML for whom RYDAPT (midostaurin)that exceeds 3271 bp (schematic on back page).treatment is being considered. TKD Mutations of FLT3The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in theThe LeukoStrat CDx FLT3 Mutation Assay uses primers that lie on assessment of patients with AML for whom XOSPATA (gilteritinib)either side of the TKD region. The FLT3 target region is amplified treatment is being considered.using PCR and then an EcoRV restriction digest is performed.Wild-type alleles of the FLT3 gene yield digestion products of 791 bp The test is for use on the 3500xL Dx Genetic Analyzer. whereas mutant alleles yield products of 1251 bp or 1271 bp from the original undigested amplicon product of 1451 bp or 1471 bp,as measured by this assay (schematic on back page).Summary and Explanation of the TestReferenceAcute myelogenous leukemia (AML) in general has a poor prognosis.Many studies in AML have shown that the presence of FLT3 activating1. Murphy KM et al., A Clinical PCR/Capillary Electrophoresis Assay for mutations portends a poor prognosis making it an attractive target forthe Detection of Internal Tandem Duplication and Point Mutation of treatment. 1,2 the FLT3 Gene. J. Mol. Diag. 5:96-102 (2003).2. Yamamoto, Y., et al., Activating mutation of D835 within the The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3activation loop of FLT3 in human hematologic malignancies. Blood, gene to identify internal tandem duplication (ITD) mutations and97(8):2434-9 (2001).tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations.The LeukoStrat CDx FLT3 Mutation Assay includes reagents, software and procedures for isolating mononuclear cells and extracting DNA from patient peripheral blood or bone marrow specimens to determine if FLT3 mutations are present.DNA is amplified via PCR and the amplicons are detected via capillary electrophoresis. FLT3 mutation status is determined by the LeukoStrat CDx FLT3 Software. A FLT3 ITD and/or TKD mutation is reported as Positive if the mutant:wild-type signal ratio meets or exceeds the clinical cutoff of 0.05.86'