Invivoscribe 2019 | 31 NGS RUO Assays 30 LymphoTrack Assay kits are designed for the identification of gene rearrangements in hematologic samples utilizing next-generation sequencing (NGS) technologies. These assays take advantage of the wealth and depth of NGS data generated with either the Illumina® MiSeq® or the Thermo Fisher Scientific® Ion PGM™ and Ion S5™ platforms. They offer significant improvements over conventional clonality testing methods, by providing the distribution of gene rearrangements, DNA sequences, the mutational status (IGH only), and the ability to track specific gene rearrangements all with the same workflow. Primers included in the master mixes are designed with Illumina® adapters and indices (8 or 24 indices configurations for a total possible 24 or *48 unique indices [*FR1 only] per framework kits) or Thermo Fisher adaptors and indices (12 indices per framework kits). By offering multiple kit configurations (8-or-24 indices for MiSeq® , 12 for Ion S5/PGM™ ), Invivoscribe further provides laboratories the ability to choose the optimal kit for their sample throughput and read-depth requirements. For the LymphoTrack IGH FR1 – MiSeq Product Line, a total of 48-unique indices are available. Testing costs can be reduced by sequencing in a single run, with the possibility to combine: a) samples with up to 48 different indices and b) amplicons from other LymphoTrack Assays. Research Use Only (RUO) assays are not for sale in Europe and other global markets where equivalent CE-IVD assays are available and registered with the appropriate regulatory agencies. For more information regarding the CE-marked LymphoTrack® Dx Assays, please refer to the preceding pages. LymphoTrack IGHV Leader Somatic Hypermutation Assay  32 LymphoTrack IGH FR1/2/3 Assays  34 LymphoTrack IGH FR1/2/3 Assays Continued  36 LymphoTrack IGK Assays  38 LymphoTrack TRG Assays  40 LymphoTrack TRB Assay  42 LymphoTrack Bioinformatics Software  44 Key Benefits  One-step PCR for amplicon and library generation  Identify and assess mutation status of B- and T-cell gene rearrangements  Sequence amplicons from any LymphoTrack kit together  Included bioinformatics software for easy analysis and interpretation  Same reagents for clonality, somatic hypermutation (SHM), minimal residual disease (MRD) testing, and tracking/monitoring of immunotherapy constructs Warranty and Liability Invivoscribe® (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 the products listed in the section that follows may be covered by one or more of the following: United States Patent 7785783, and additional patents and patent applications pending in the United States and elsewhere. All of these patents and applications are licensed exclusively to Invivoscribe® worldwide (except Australia) across the field of hematopathology, including diagnostics, monitoring, prognosis and treatment. 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. Next-Generation Sequencing (NGS) Research Use Only (RUO) Assays