b'Next-GenerationAssaysSequencing (NGS) LymphoTrack Dx Assay kits are designed forAssays the identification of gene rearrangements in Next-Generation Sequencing (NGS)Assays hematologic samples utilizing next-generation sequencing (NGS) technologies. Key Benefits One-step PCR for amplicon and library generationIdentify, track, and assess mutation status of B- and T-cell gene rearrangements These assays take advantage of the wealth and depth of data generated by the IlluminaMiSeq, Thermo Fisher Scientific Ion PGM and Ion S5 platforms. Sequence amplicons from any LymphoTrack Dx kit togetherThe Invivoscribe NGS assays offer significant improvements over conventional fragment analysis of B- and T-cellIncluded bioinformatics software for easy analysis and interpretation gene rearrangements by providing detailed information regarding the DNA sequences, sequence frequency, andmutational status (IGHV Leader and IGH FR1 only) of each clonotype.LymphoTrack Dx Assay kits are a complete solution. Kits contain ready-to-use indexed amplification master Key Benefits mixes, necessary controls, and complimentary bioinformatics software. As primers are designed with barcoded 24/ LymphoTrackDx IGHV Leader Somatic32/ LymphoTrackDxindices and adapters, sequencing libraries can be generated with a single PCR, streamlining the overall workflow, Hypermutation Assay TRG AssaysOne-step PCR for amplicon and library generationeliminating the need for a post-PCR ligation step, and reducing the potential for sample cross contamination. 26/ LymphoTrackDx 34/ LymphoTrackDxangements The per sample testing costs can be reduced by pooling samples from different LymphoTrack Dx Assays into a Identify, track, and assess mutation status of B- and T-cell gene rearr IGH FR1/2/3 Assays TRB AssaysSequence amplicons from any LymphoTrack Dx kit together single sequencing run. The included bioinformatics software will sort the complex NGS data for easy analysis and30/ LymphoTrackDx36/ LymphoTrackDxvisualization of individual samples.IGK Assays Bioinformatics SoftwareIncluded bioinformatics software for easy analysis and interpretationDetailed instructions for use are provided with all kits and the Invivoscribe technical support team is always available to answer your questions.For more information, please visit www.invivoscribe.comWarranty and LiabilityInvivoscribe, 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 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: These are in vitro diagnostic products and are not available for sale or use within North America. Many of the products listed in the section that follows are 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: The LymphoTrack Dx Assays are in vitro diagnostic products and are not available 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. for sale or use within North America. For more information regarding the research use only reagents, please see the Next-Generation Sequencing - LymphoTrack section. Invivoscribe 2021|23'