b'CDxTestingFDA APPROVEDTest Name The TKD PCR product is further digested with a restriction LeukoStrat CDx FLT3 Mutation Assay enzyme. The ITD PCR products and the digested TKD PCR products are analyzed on a capillary electrophoresis instrument. Assay TypeFLT3 ITDs are detected by a change in the expectedCapillary Electrophoresis size of a wild type fragment. An amplicon larger thanthe wild type fragment indicates the presence of FLT3 ITD.Method Description The TKD digestion pattern identifies loss of the normalgene sequences and ensures that digestion occurred. The LeukoStrat CDx FLT3 Mutation Assay is designed to detect ITD and TKD mutations in the FLT3 gene.Indications for TestingThe 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 are used to amplify DNA extracted from a patient sample. with XOSPATA (gilteritinib fumarate).Interpretation TurnaroundSpecimen Requirements ShippingSpecimen Time Conditions StabilityAn interpretive2 to 3 Recommended Specimen Volume2C to 8C up to2C to 8C up report will bebusiness days(Preservative) 72 hours; do notto 7 daysissued, indicating2 mL of peripheral blood infreeze.whether the patient95% patientSodium Heparin or EDTAis eligible forsamples are midostaurin and/orreported within0.5mL of bone marrow in gilteritinib fumarate48 hours ofSodium Heparin or EDTAtreatment receipt Minimum Specimen Volume (Preservative)1mL of peripheral blood in Sodium Heparin or EDTA0.25 mL of bone marrow in Sodium Heparin or EDTALabPMM Services Catalog 2021|13'