Invivoscribe 2019 | 87 Gel & Capillary RUO Assays 86 Gel and Capillary Research Use Only (RUO) Assays Invivoscribe offers an array of assays for B- and T-cell gene clonality/ rearrangements, mutations, and chromosome translocations for the assessment of hematologic malignancies. These (RUO) assays are available for either ABI capillary electrophoresis fluorescence, or PAGE/agarose gel detection, and contain the PCR master mixes, recommended controls, and Instructions For Use. On the following pages, you will find detailed information on each RUO assay, including: assay use, background information, typical output data, kit contents, and ordering information. These assays are available in regular sizes (30 or 33 reactions) or high-volume MegaKit formats (300 or 330 reactions). Please note that RUO assays are not for sale in Europe and other global markets, where products have been registered, if an equivalent CE-IVD registered product targeting the same locus is available. Refer to the preceding pages for information regarding our IdentiClone™ and LeukoStrat® CE-IVD Assays. For more information, please visit www.invivoscribe.com B-Cell Assays IGH + IGK B-Cell Clonality Assays 88 IGH Gene Rearrangement Assays 90 IGH Gene Clonality Assays 92 IGK Gene Clonality Assays 94 IGL Gene Clonality Assays 96 T-Cell Assays TCRB + TCRG T-Cell Clonality Assays 98 TCRB Gene Clonality Assays 100 T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 102 T-Cell Receptor Gamma Gene Rearrangement Assays 104 TCRG Gene Clonality Assays 106 TCRD Gene Clonality Assays 108 Translocation Assays BCL1/JH Translocation Assay 110 BCL2/JH t(14;18) Translocation Assay 112 BCL2/JH Translocation Assay 114 BCR/ABL t(9;22) Translocation Assays 116 PML/RARα t(15;17) Translocation Assays 118 Mutation Assays IGH Somatic Hypermutation Assays v2.0 120 FLT3 Mutation Assays 122 Warranty and Liability Invivoscribe, Inc. (Invivoscribe® ) is committed to providing the highest quality products. Invivoscribe® warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe® . Invivoscribe® liability shall not exceed the purchase price of the product. Invivoscribe shall have no liability for direct, indirect, consequential or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’s laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph. NOTICE: Many of these products in the section that follows are covered by one or more of the following: European Patent Number 1549764, European Patent Number 2418287, European Patent Number 2460889, Japanese Patent Number 4708029, United States Patent 8859748, and related pending and future applications. All of these patents and applications are licensed exclusively to Invivoscribe, Inc. Additional patents licensed to Invivoscribe covering some of these products apply elsewhere. These products require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license under these patents to use amplification processes or enzymes is conveyed expressly or by implication to the purchaser by the purchase of these products. Gel and Capillary Research Use Only (RUO) Assays