b'Gel & Capillary | IVD Assays FLT3 Mutation Assay 2.0Gel and Capillary Assays andAssaysABI Fluorescence Detection FLT3 Mutation Assay 2.0 -ABI Fluorescence DetectionAssay Description Table 1. FLT3 ITD Percent Agreement with 454 SequencingThe LeukoStrat FLT3 Mutation Assay 2.0 is an in vitro diagnosticPercent Agreement Discordance # Concordance # *95% LLproduct intended for PCR-based detection of FLT3 activating mutations in patients with acute myelogenous leukemia (AML). Negative PA 100% 0 119 96.9%Specifically, the FLT3 Mutation Assay 2.0 can be used to: Positive PA 98.0% 4 200 95.1%Identify internal tandem duplications (ITD) in the FLT3 gene * 95% of results would be expected to agree with sequencing at a rate greater than Identify tyrosine kinase domain (TKD) mutations in the FLT3 gene or equal to the lower limit (LL).Summary and Explanation of the TestTable 2. FLT3 TKD Percent Agreement with 454 SequencingAML in general has a poor prognosis. 1,2Assessment of the mutation status of the FLT3 (fms related tyrosine kinase 3) receptor gene is thePercent Agreement Discordance # Concordance # *95% LLmost important prognostic indicator of disease outcome, occurring in approximately 30% of patients at the time of diagnosis. 3For this reason,Negative PA 100% 0 137 96.9%testing for FLT3 activating mutations is required for the stratificationof disease and determination of appropriate treatment options. Positive PA 100% 0 240 98.5%The LeukoStrat FLT3 Mutation Assay 2.0 is a PCR-based method*95% of results would be expected to agree with sequencing at a rate greater thanthat identifies ITD and TKD mutations. This test kit includes 2 masteror equal to the lower limit (LL).mixes: the FLT3-ITD Master Mix for the detection of ITD mutations and FLT3-D835 Master Mix for the detection of TKD region mutations(such as the D835 and I836 mutations).Performance CharacteristicsReferenceThe LeukoStrat FLT3 Mutation Assay 2.0 is a rapid and reliable1. Murphy KM et al., A Clinical PCR/Capillary Electrophoresis Assay for method for the detection of FLT3 mutations, as evidenced bythe Detection of Internal Tandem Duplication and Point Mutation of comparison with Roche 454 sequencing. the FLT3 Gene. J. Mol. Diag. 5:96-102 (2003).2. Yamamoto, Y., et al., Activating mutation of D835 within the The FLT3 Mutation Assay 2.0 is capable of detecting FLT3-ITD andactivation loop of FLT3 in human hematologic malignancies. Blood, TKD mutations with excellent concordance (Table 1 and 2) and has97(8):2434-9 (2001).high reliability when multiple standard laboratory variables are3.Acute Myeloid Leukemia, Clinical Practice Guidelines in Oncology, considered, including multiple operators, reagent lots, different ABINational Comprehensive Cancer Network (v.2.2014)3500xL instruments, and nonconsecutive testing days.84'