b'Gel & Capillary | IVD Assays FLT3 Mutation Assay - Gel DetectionGel and Capillary Assays andAssaysFLT3 Mutation Assay - Gel DetectionAssay DescriptionPerformance Characteristics The LeukoStrat FLT3 Mutation Assay is an in vitro diagnostic productThis LeukoStrat FLT3 Mutation Assay offers a rapid and reliable intended for PCR-based detection of FLT3 activating mutations inmethod for detecting FLT3 mutations. This is shown by a validation patients with acute myelogenous leukemia (AML). performed by the Laboratory for Personalized Molecular Medicine (LabPMM). Specifically, the FLT3 Mutation Assay can be used to:Identify internal tandem duplications (ITD) in the FLT3 gene Concordance with three independent labsIdentify tyrosine kinase domain (TKD) mutations in the FLT3 gene ITD 100% sensitivity / 100% specificity TKD 100% sensitivity / 100% specificitySummary and Explanation of the Test AML in general has a poor prognosis. Assessment of the mutation statusLabPMM tested 57 blinded patient samples obtained from three of the FLT3 (fms related tyrosine kinase 3) receptor gene in karyotypeindependent institutions. The institutions determined that 13 of the normal AML is the most important prognostic indicator of diseasesamples were FLT3 ITD positive, 33 were FLT3 ITD negative, 6 were outcome, which is often substantial, as many studies in AML haveFLT3 TKD positive, and 50 were FLT3 TKD negative. In addition 10 shown that the presence of FLT3 activating mutations portends a poorpositive blinded spiked samples and 10 negative samples were used prognosis. 1, 2For this reason, FLT3 activation mutation testing is requiredfor the validation of FLT3 TKD. The LeukoStrat FLT3 Mutation Assay to stratify disease and determine appropriate treatment options. Thisshowed a sensitivity and specificity of 100% with both master mixes. LeukoStrat PCR assay targets regions of the FLT3 gene to identify ITDThe analytical sensitivity of both master mixes was determined to be mutations and TKD mutations, such as the D835 and I836 mutations. 5 positive cells out of 100 total cells.This assay cannot reliably detect FLT3 mutations comprising less than 5% of the total cell population. It should be emphasized that the resultsReferenceof molecular mutation tests should always be interpreted in the context of clinical, histological and immunophenotypic data. 1. Murphy KM et al., A Clinical PCR/Capillary Electrophoresis Assay for the Detection of Internal Tandem Duplication and Point Mutation of This test kit includes 3 master mixes. (1) FLT3 ITD Master mix tests forthe FLT3 Gene. J. Mol. Diag. 5:96-102 (2003).internal tandem duplication mutations. (2) FLT3 D835 Master Mix tests2. Yamamoto, Y., et al., Activating mutation of D835 within the for TKD region mutations. (3) The Specimen Control Size Ladder masteractivation loop of FLT3 in human hematologic malignancies. Blood, mix targets multiple genes and generates a series of amplicons of97(8):2434-9 (2001).approximately 100, 200, 300, 400, and 600 basepairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result.82'