b'Gel & Capillary | RUO AssaysGel and Capillary Gel and CapillaryFLT3 Mutation Assays Research Use Only (RUO) Assay FLT3 Mutation Assays Research Use Only (RUO) AssayFLT3 Mutation AssaysReagentsControls Concentration Units in 33 Reaction Assay Units in 330 Reaction MegaKitThese products are not available for sale or use in the United States.IVS-0017 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesIVS-P001 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesAssay Use Specimen RequirementsIVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesMaster Mixes Target Units in 33 Reaction Assay Units in 330 Reaction MegaKitThese Research Use Only assays identify FLT3 mutations. High quality genomic DNA FLT3 ITD Master Mix FLT3 ITD 1 x 1500 L tube 10 x 1500 L tubesSummary and Explanation of the TestFLT3 D835 Master Mix FLT3 TKD 1 x 1500 L tube 10 x 1500 L tubesReferencesSpecimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubesFLT3 Mutation Assays target regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD)https://clinicaltrials.govmutations, such as the D835 and I836 mutations. DNA is amplified by1. Acute Myeloid Leukemia, Clinical Practice Guidelines in Oncology, PCR, TKD amplicon is enzymatically digested, and FLT3 mutations areNational Comprehensive Cancer Network (v.2.2014). Gel Electrophoresis Detection detected via agarose gel (catalog #14120010 or #14120020) or capillary2. Lowenberg, B. et al.Acute myeloid leukemia. N Engl J Med (catalog #14120031 or #14120041) electrophoresis. 341(14):1051-62 (1999). Data was generated using the FLT3 ITD Master Mix, and amplified products were run on a 2% TBE Assay kits include three PCR master mixes, along with positive and3. Thiede, C. et al. Analysis of FLT3-activating mutations in 979agarose gel alongside a 100bp DNA size ladder. Lane 1 is a FLT3 ITD control*; lane 2 is a 10% dilution of a negative controls. FLT3 ITD master mix tests for internal tandempatients with acute myelogenous leukemia: association with FABFLT3 ITD control; and lane 3 is IVS-0000, which is representative of a wild type product. duplication mutations. FLT3 D835 master mix tests for TKD regionand identification of subgroups with poor prognosis. Blood 99(12):*IVS-0050 performs comparable to IVS-0017 clonal control DNA, which is included in the kit as the positive control.mutations. The Specimen Control Size Ladder master mix targets4326-35 (2002).multiple genes and generates a series of amplicons of approximately4. Nakao, M. et al. Internal tandem duplication of the FLT3 gene 100, 200, 300, 400, and 600 base pairs to ensure that the quality andfound in acute myeloid leukemia. Leukemia 10(12):1911-18 (1996).quantity of input DNA is adequate to yield a valid result. 5. Yamamoto, Y et al. Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood, Master mixes contain fluorophore-labeled (capillary) or unlabeled (gel)97(8):2434-9 (2001).primer sets as appropriate to kit detection method. 6. Gilliland, DG et al. The roles of FLT3 in hematopoiesis and leukemia. Blood 100(5):1532-154 (2002).BackgroundCapillary Electrophoresis Detection (ABI)Data was generated using the FLT3 ITD Master Mix and amplified products were run FLT3 is a receptor tyrosine kinase that is normally expressed onon an ABI 3100 instrument. Templates analyzed follow: Panel 1 is the FLT3 ITD positive many cell types including hematologic stem cells.Mutation of thecontrol; panel 2 is a 10% dilution of the positive control; and Panel 3 is IVS-0000, which FLT3 receptor, by either internal tandem duplication (ITD) of theis representative of a wild type product.juxtamembrane domain or point mutation in the activation loop of the tyrosine kinase domain (TKD), causes constitutive activation of the FLT3 receptor.Such gain-of-function mutations in the FMS related tyrosine kinase 3 (FLT3) gene are the subject of research studies and multiple clinical trials targeting Acute Myeloid Leukemia (AML) subjects. The mostOrdering Informationprevalent type of FLT3 mutation is an internal tandem duplication inCatalog # Products Quantityand around the juxtamembrane domain.The second most common mutation type in the FLT3 gene is a TKD point mutation in aspartate1-412-0010 FLT3 Mutation Assay - Gel Detection 33 reactions(D835) or isoleucine (I836).1-412-0020 FLT3 Mutation Assay MegaKit - Gel Detection 330 reactions1-412-0031 FLT3 Mutation Assay - Gel Detection 33 reactions1-412-0041 FLT3 Mutation Assay MegaKit - ABI Fluorescence Detection 330 reactionsDISCLAIMER RUO assays are Research Use Only; Not available for use in diagnostic procedures, and additionally not available for sale or use in regions where CE-IVD products are registered.These products are not available for sale or use in the United States. Please see the LeukoStrat CDx FLT3 Mutation Assay product pages for IVD product availability in the United States and other global regions.126Invivoscribe 2021|127'