b'LeukoStrat CDx FLT3 MutationCDx TestingAssay - JapanPredictive test for the efficacy of XOSPATA (Gilteritinib Fumarate)and VANFLYTA TM(Quizartinib Hydrochloride) Intended Use Test Name enzyme. The ITD PCR products and the digested TKD The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based,The LeukoStrat CDx FLT3 Mutation Assay is used as an aidLeukoStrat CDx FLT3 Mutation Assay PCR products are analyzed on a capillary electrophoresis in vitro diagnostic test designed to detect internal tandemin the assessment of patients with AML for whom Gilteritinibinstrument. duplication (ITD) mutations and tyrosine kinase domainFumarate treatment is being considered. (TKD) mutations D835 and I836 in the FLT3 gene in genomicAssay Type FLT3 ITDs are detected by a change in the expectedDNA extracted from mononuclear cells obtained fromThe LeukoStrat CDx FLT3 Mutation Assay is used as ansize of a wild type fragment. An amplicon larger thanperipheral blood or bone marrow aspirates of patientsaid in the assessment of patients with AML for whomCapillary Electrophoresis the wild type fragment indicates the presence of FLT3 ITD. diagnosed with acute myelogenous leukemia.Quizartinib Hydrochloride treatment is being considered. The TKD digestion pattern identifies loss of the normalMethod Description gene sequences and ensures that digestion occurred. The LeukoStrat CDx FLT3 Mutation Assay is designed Indications for Testingto detect ITD and TKD mutations in the FLT3 gene. At initial diagnosis of AMLThe assay is performed on DNA isolated from mononuclearAs a tool for the assessment of AML patients for whom cells obtained from peripheral blood or bone marrow 1 Mutations in the FLT3 gene are the most common mutations found in AML gilteritinib fumarate treatment is being consideredaspirates of patients diagnosed with AML. As a tool for the assessment of AML patients for whom2 Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable Primers targeting both in and around the juxtamembranequizartinib hydrochloride treatment is being consideredregion for ITD testing and kinase domain of the FLT3 gene are used to amplify DNA extracted from a patient sample. 3 The LeukoStrat CDx FLT3 Mutation Assay is the first PMDA approved test for assessment of AMLThe TKD PCR product is further digested with a restriction patients eligible for treatment with gilteritinib fumarate or quizartinib hydrochloride Interpretation TurnaroundSpecimen Requirements ShippingStorage 4 Gilteritinib fumarate received manufacturing and marketing approval for the treatment of FLT3Time Conditions Conditionsmutation-positive relapse or refractory AML in Japan An interpretive2 to 3 3 mL of peripheral blood in2C to 8C up to2C to 8C upreport will bebusiness dayssodium heparin or EDTA 72 hours; do notto 7 days5 Quizartinib hydrochloride is MHLW/PMDA approved for the treatment of relapsed/ refractory issued, indicatingtubes only freeze.FLT3-ITD +AMLwhether the 95% of patient1 mL of bone marrow in sodium patient is eligiblesamples reportedheparin or EDTA tubes onlyfor gilterinibwithin 48 hours fumarate treatmentof receiptor quizartinib hydrochloride18 LabPMM Services Catalog 2020|19'