b'Gel & Capillary | IVD Assays Gel & CapillaryCDx FLT3 Mutation Assay - AUSCDx FLT3 Mutation Assay - AUS IVD AssaysGel and Capillary Assays andAssays Gel and Capillary Assays andAssaysARTG-Approved Assay Available in AustraliaCDx FLT3 Mutation AssayThe only internationally standardized IVD assay for FLT3 Signal Ratio mutation analysis for selection of acute myeloid leukemia (AML) patients eligible for treatment with midostaurin.Intended Use Method DescriptionThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitroITD Mutations of FLT3 diagnostic test designed to detect internal tandem duplicationsThe LeukoStrat CDx FLT3 Mutation Assay uses fluorescently labeled (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836primers that are in and around the JM region. Wild-type FLT3 alleles in the FLT3 gene in genomic DNA extracted from mononuclear cellswill amplify and produce a product at 3271 bp as measured by this obtained from peripheral blood or bone marrow aspirates of patientsassay, while alleles that contain ITD mutations will produce a product diagnosed with acute myelogenous leukemia (AML).that exceeds 3271 bp (see Figure, right).In regions where midostaurin is available, theLeukoStrat CDx FLT3TKD Mutations of FLT3Mutation Assay is used as an aid in the selection of patients with AML for whom midostaurin treatment is being considered.The LeukoStrat CDx FLT3 Mutation Assay uses primers that lie on either side of the TKD region. The FLT3 target region is amplified using PCR and then an EcoRV restriction digest is performed. Wild-type Summary and Explanation of the Test alleles of the FLT3 gene yield digestion products of 791 bp whereas mutant alleles yield products of 1251 bp or 1271 bp from the original 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 (see Figure, right). Depicted is a representation of the FLT3 juxtamembrane (JM) region (TM = transmembrane) and the activating loop of the tyrosine kinase normal AML is the most important prognostic indicator of disease(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 outcome, which is often substantial, as many studies in AML havethe kinase domain for TKD. Colored dots represent fluorophores on labeled primers. The yellow box has vertical black lines that represent the References position of the EcoRV restriction digest sites.shown that the presence of FLT3 activating mutations portends a poor prognosis. 1,2The LeukoStrat CDx FLT3 Mutation Assay targets regions of1. Murphy KM et al., A Clinical PCR/Capillary Electrophoresis Assay for the FLT3 gene to identify ITD mutations and TKD mutations, such as thethe Detection of Internal Tandem Duplication and Point Mutation of D835 and I836 mutations, and has been validated in an internationalthe FLT3 Gene. J. Mol. Diag. 5:96-102 (2003). Reagentsclinical trial. 2. Yamamoto, Y., et al., Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood,Controls Units in AssayThe LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment,97(8):2434-9 (2001). FLT3 Extraction Control 1 x 1800 L tubesoftware and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present.FLT3 ITD Master Mix 1 x 1500 L tubeDNA is amplified via PCR and the amplicons are detected via capillaryFLT3 TKD Master Mix 1 x 1500 L tubeelectrophoresis. FLT3 mutation status is determined by the LeukoStrat CDx FLT3 Software. A FLT3 ITD and/or TKD mutation is reported asFLT3 ITD Positive Control 1 x 100 L tubePositive if the mutant:wild-type signal ratio meets or exceeds the clinicalFLT3 TKD Positive Control 1 x 100 L tubecutoff of 0.05. FLT3 No Template Control 1 x 200 L tubeAll reagents should be stored at -15 to -30 degrees C.Ordering InformationCatalog # Products QuantityK-412-0381 LeukoStrat CDx FLT3 Mutation Assay33 reactionsK-412-0391 LeukoStrat CDx FLT3 Mutation Assay Software 1 CD complimentary with purchaseThese are in vitro diagnostic products, and are available for sale only within Australia.90Invivoscribe 2021|91'