b'CDxMHLW/PMDA APPROVED TestingTest Name enzyme. The ITD PCR products and the digested TKD LeukoStrat CDx FLT3 Mutation Assay PCR products are analyzed on a capillary electrophoresis instrument. Assay Type FLT3 ITDs are detected by a change in the expectedsize of a wild type fragment. An amplicon larger thanCapillary Electrophoresis the wild type fragment indicates the presence of FLT3 ITD. 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 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. The TKD PCR product is further digested with a restriction Interpretation TurnaroundSpecimenShippingReimbursement Time Requirements Conditions PointsAn interpretive2 to 3 Recommended Specimen2C to 8C up to 4200 pointsreport will bebusiness daysVolume (Preservative) 72 hours; do not issued, indicating2 mL of peripheral bloodfreeze.whether the 95% of patientin Sodium Heparin or EDTApatient is eligiblesamples reported0.5mL of bone marrow Specimen for gilterinibwithin 48 hours fumarate treatmentof receipt in Sodium Heparin or EDTA Stabilityor quizartinibMinimum Specimen Volume hydrochloride (Preservative) 2C to 8C upto 7 days1mL of peripheral blood in Sodium Heparin or EDTA0.25 mL of bone marrow in Sodium Heparin or EDTALabPMM Services Catalog 2021|17'