b'CDxLeukoStrat CDx FLT3 MutationMHLW/PMDA APPROVED TestingAssay - JapanPREDICTIVE TEST FOR THE EFFICACY OF XOSPATA (GILTERITINIB FUMARATE)AND VANFLYTA TM(QUIZARTINIB HYDROCHLORIDE) Test Name enzyme. The ITD PCR products and the digested TKD LeukoStrat CDx FLT3 Mutation Assay PCR products are analyzed on a capillary electrophoresis instrument. Intended UseFLT3 ITDs are detected by a change in the expectedThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-based,The LeukoStrat CDx FLT3 Mutation Assay is used as an aidAssay Type size of a wild type fragment. An amplicon larger thanin vitro diagnostic test designed to detect internal tandemin the assessment of patients with AML for whom GilteritinibCapillary Electrophoresis the wild type fragment indicates the presence of FLT3 ITD. duplication (ITD) mutations and tyrosine kinase domainFumarate treatment is being considered.The TKD digestion pattern identifies loss of the normal(TKD) mutations D835 and I836 in the FLT3 gene in genomicgene sequences and ensures that digestion occurred. DNA extracted from mononuclear cells obtained fromThe LeukoStrat CDx FLT3 Mutation Assay is used as anMethod Descriptionperipheral blood or bone marrow aspirates of patientsaid in the assessment of patients with AML for whomThe LeukoStrat CDx FLT3 Mutation Assay is designeddiagnosed with acute myelogenous leukemia.Quizartinib Hydrochloride treatment is being considered. to detect ITD and TKD mutations in the FLT3 gene.Indications for TestingAt initial diagnosis or relapse 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 aspirates of patients diagnosed with AML.gilteritinib fumarate treatment is being consideredAs a tool for the assessment of AML patients for whomPrimers 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. 1 Mutations in the FLT3 gene are the most common mutations found in AML The TKD PCR product is further digested with a restriction 2 Presence of a FLT3 activation mutation in patients with AML may be prognostic and clinically actionable. Interpretation TurnaroundSpecimenShippingReimbursement Time Requirements Conditions Points3 The LeukoStrat CDx FLT3 Mutation Assay is the first PMDA approved test for assessment of AML patientsAn interpretive2 to 3 Recommended Specimen2C to 8C up to 4200 pointseligible for treatment with gilteritinib fumarate or quizartinib hydrochloridereport will bebusiness daysVolume (Preservative) 72 hours; do not issued, indicating2 mL of peripheral bloodfreeze.whether the 95% of patientin Sodium Heparin or EDTA4 Gilteritinib fumarate received manufacturing and marketing approval for the treatment of FLT3 mutation- patient is eligiblesamples reported0.5mL of bone marrow Specimen positive relapse or refractory AML in Japan for gilterinibwithin 48 hours fumarate treatmentof receipt in Sodium Heparin or EDTA Stabilityor quizartinibMinimum Specimen Volume 5 Quizartinib hydrochloride is MHLW/PMDA approved for the treatment of relapsed/ refractory hydrochloride (Preservative) 2C to 8C upFLT3-ITD +AML to 7 days1mL of peripheral blood in Sodium Heparin or EDTA0.25 mL of bone marrow in Sodium Heparin or EDTA16 LabPMM Services Catalog 2021|17'