Test Name LeukoStrat® CDx FLT3 Mutation Assay Assay Type Capillary Electrophoresis Method Description The LeukoStrat® CDx FLT3 Mutation Assay is designed to detect ITD and TKD mutations in the FLT3 gene. The assay is performed on DNA isolated from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. Primers targeting both the juxtamembrane region 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 enzyme. The ITD PCR products and the digested TKD PCR products are analyzed on a capillary electrophoresis instrument. Indications for Testing In regions where midostaurin is available, the LeukoStrat CDx FLT3 mutation assay is used as an aid in the assessment of AML patients for whom midostaurin treatment is being considered. Interpretation Turn-around Time Specimen Requirements Shipping Conditions Storage Conditions An interpretive report will be issued indicating the absence or presence of a FLT3 mutation and its corresponding signal ratio. The report will further indicate whether the patient is eligible for a therapy with midostaurin. 2 to 3 business days •  3 mL of peripheral blood in sodium heparin tubes only •  1 mL of bone marrow in sodium heparin tubes only  2°C to 8°C up to 72 hours; Do not freeze.  2°C to 8°C up to 7 days CDx Testing LabPMM Services Catalog 2019 | 15 Intended Use The LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). In regions where midostaurin is available, the LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the selection of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered. LeukoStrat ® CDx FLT3 Mutation Assay - EU Mutations in the FLT3 gene are the most common mutations found in AML Presence of a FLT3 mutation in patients with AML is both highly prognostic and clinically actionable Midostaurin was approved by the FDA, Swissmedic and European Comission for the treatment of adult patients with newly diagnosed AML who are FLT3 mutation positive The LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the assessment of AML patients for whom midostaurin treatment is being considered 14 Predictive test for the efficacy of midostaurin