b'LymphoTrack Assay kits are designed for the identification of gene rearrangements in Next-Generation Sequencing (NGS) RUO Assays hematologic samples utilizing next-generation sequencing (NGS) technologies.Key BenefitsOne-step PCR for amplicon and library generation Identify and assess mutation status of B- and T-cell gene rearrangementsThese assays take advantage of the wealth and depth of NGS data generated Sequence amplicons from any LymphoTrack kit together with either the Illumina MiSeq or the Thermo Fisher Scientific Ion PGM andIncluded bioinformatics software for easy analysis and interpretation Ion S5 platforms. They offer significant improvements over conventional clonalitytesting methods, by providing the distribution of gene rearrangements, DNAeagents for clonality, somatic hypermutation (SHM), minimal residual disease (MRD) testing,Same rand tracking/monitoring of immunotherapy constructs 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 40/ LymphoTrack IGHV Leader Somatic48/ LymphoTrackconfigurations for a total possible 24 or *48 unique indices [*FR1 only] per framework kits) or Thermo Fisher Hypermutation Assay TRG Assays adapters and indices (12 indices per framework kits). By offering multiple kit configurations (8-or-24 indices for MiSeq, 12 for Ion S5/PGM), Invivoscribe provides laboratories the ability to choose the optimal kit 42/ LymphoTrack IGH50/ LymphoTrackfor their sample throughput and read-depth requirements. Testing costs can be reduced by sequencing in a FR1/2/3 Assays TRB Assay single run, with the possibility to combine: a) samples with up to 48 different indices and b) amplicons from other 46/ LymphoTrack IGK52/ LymphoTrackLymphoTrack Assays.Assays Bioinformatics SoftwareWARRANTY AND LIABILITYInvivoscribe (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 purchasers 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 patents and patent applications owned by or exclusively licensed to Invivoscribe, Inc.:United States Patent Number 7,785,783, United States Patent Number 8,859,748, United States Patent 10,280,462, European Patent Number EP 1549764B1 (validated in 16 countries, and augmented by related European Patents Numbered EP2418287A3 and EP 2460889A3), Japanese Patent Number JP04708029B2, Japanese Patent Application Number 2006-529437, Brazil Patent Application Number PI0410283.5, Canadian Patent Number CA2525122, Indian Patent Number IN243620, Mexican Patent Number MX286493, Chinese Patent Number CN1806051, and Korean Patent Number 101215194. These products use nucleic acid amplification methods such as Polymerase Chain Reaction (PCR).Any necessary license to practice amplification methods or to use reagents, amplificationDISCLAIMER: 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 enzymes or equipment covered by third party patents is the responsibility of the user and no such license is granted by Invivoscribe, Inc., expressly or by implication. regulatory agencies. For more information regarding the CE-marked LymphoTrack Dx Assays, please refer to the preceding pages.Invivoscribe 2021|39'