b'Gel & Capillary | IVD Assays CDx FLT3 Mutation Assay (CE-marked)Gel and Capillary Assays andAssays CDx FLT3 Mutation Assay (CE-marked)Gel and Capillary Assays andAssaysCE-marked AssayCDx FLT3 Mutation AssayThe only internationally standardized CE-IVD assay for FLT3 Signal Ratio mutation analysis for assessment of acute myeloid leukemia (AML) patients eligible for treatment with RYDAPT (midostaurin) or XOSPATA (gilteritinib fumarate).Intended Use electrophoresis. FLT3 mutation status is determined by the LeukoStrat The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitroCDx FLT3 Software. A FLT3 ITD and/or TKD mutation is reported as diagnostic test designed to detect internal tandem duplicationsPositive if the mutant:wild-type signal ratio meets or exceeds the clinical (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836cutoff of 0.05. in the FLT3 gene in genomic DNA extracted from mononuclear cellsMethod Descriptionobtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). ITD Mutations of FLT3 In regions where midostaurin is available, the LeukoStrat CDx FLT3The LeukoStrat CDx FLT3 Mutation Assay uses fluorescently labeled Mutation Assay is used as an aid in the assessment of patients withprimers that are in and around the JM region. Wild-type FLT3 alleles AML for whom RYDAPT (midostaurin) treatment is being considered. will amplify and produce a product at 3271 bp as measured by this assay, while alleles that contain ITD mutations will produce a product In regions where gilteritinib fumarate is available, the LeukoStrat CDxthat exceeds 3271 bp (see Figure, right). FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA (gilteritinib fumarate) treatment isTKD Mutations of FLT3being considered. The LeukoStrat CDx FLT3 Mutation Assay uses primers that lie on either side of the TKD region. The FLT3 target region is amplified usingDepicted is a representation of the FLT3 juxtamembrane (JM) region (TM = transmembrane) and the activating loop of the tyrosine kinase PCR and then an EcoRV restriction digest is performed. Wild-type(TK) domain. Black arrows represent the relative positions of primers that target in and around the JM region for ITD or the activating loop of Summary and Explanation of the Test alleles of the FLT3 gene yield digestion products of 791 bp whereasthe kinase domain for TKD. Colored dots represent fluorophores on labeled primers. The yellow box has vertical black lines that represent the mutant alleles yield products of 1251 bp or 1271 bp from the originalposition of the EcoRV restriction digest sites.AML in general has a poor prognosis. Assessment of the mutation statusundigested amplicon product of 1451 bp or 1471 bp, as measured by of the FLT3 (fms related tyrosine kinase 3) receptor gene in karyotypethis assay (please see Figure, right).normal AML is the most important prognostic indicator of diseaseReagentsoutcome, which is often substantial, as many studies in AML have shown that the presence of FLT3 activating mutations portends a poorReferencesprognosis. 1,2The LeukoStrat CDx FLT3 Mutation Assay targets regions ofControls Units in Assaythe FLT3 gene to identify ITD mutations and TKD mutations, such as the1. Murphy KM et al., A Clinical PCR/Capillary Electrophoresis Assay forFLT3 Extraction Control 1 x 1800 L tubeD835 and I836 mutations, and has been validated in an internationalthe Detection of Internal Tandem Duplication and Point Mutation ofFLT3 ITD Master Mix 1 x 1500 L tubeclinical trial. the FLT3 Gene. J. Mol. Diag. 5:96-102 (2003).2. Yamamoto, Y., et al., Activating mutation of D835 within theFLT3 TKD Master Mix 1 x 1500 L tubeThe LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment,activation loop of FLT3 in human hematologic malignancies. Blood,FLT3 ITD Positive Control 1 x 100 L tubesoftware and procedures for isolating mononuclear cells and extracting97(8):2434-9 (2001).DNA from patient specimens to determine if FLT3 mutations are present.FLT3 TKD Positive Control 1 x 100 L tubeDNA is amplified via PCR and the amplicons are detected via capillaryFLT3 No Template Control 1 x 200 L tubeAll reagents should be stored at -15 to -30 degrees C.Ordering InformationCatalog # Products QuantityK-412-0291 LeukoStrat CDx FLT3 Mutation Assay33 reactionsK-412-0281 LeukoStrat CDx FLT3 Mutation Assay Software 1 CD complimentary with purchaseThese are in vitro diagnostic products, and are not available for sale or use within North America.88Invivoscribe 2021|89'