For information on this product, please refer to the manufacturer's description and instructions. Excerpts from manufacturer's description in IFU 280534 Rev. B (English; from 19. October 2023): The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (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). The LeukoStrat CDx FLT3 Mutation Assay may be used as a companion diagnostic for the following therapeutic: In regions where XOSPATA® (gilteritinib fumarate) is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA (gilteritinib fumarate) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay includes reagents and assay specific software to determine if FLT3 mutations are present in human DNA extracted from mononuclear cells isolated from patient peripheral blood or bone marrow specimens. DNA is amplified via PCR, the TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis on the 3500xL or 3500xL Dx Genetic Analyzer. FLT3 mutation status is determined by the LeukoStrat CDx FLT3 Software.