Invivoscribe 2019 | 15 NGS CE-IVD Assays 14 Key Benefits  One-step PCR for amplicon and library generation  Identify, track, and assess mutation status of B- and T-cell gene rearrangements  Sequence amplicons from any LymphoTrack Dx kit together  Included bioinformatics software for easy analysis and interpretation NOTICE: The LymphoTrack Dx Assays are in vitro diagnostic products and are not available for sale or use within North America. For more information regarding the research use only reagents, please see the Next-Generation Sequencing - LymphoTrack section. LymphoTrack Dx 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 data generated by the Illumina® MiSeq® , Thermo Fisher Scientific® Ion PGM™ and Ion S5™ platforms. The Invivoscribe NGS assays offer significant improvements over conventional fragment analysis of B- and T-cell gene rearrangements by providing detailed information regarding the DNA sequences, sequence frequency, and mutational 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 mixes, necessary controls, and complimentary bioinformatics software. As primers are designed with barcoded indices and adapters, sequencing libraries can be generated with a single PCR, streamlining the overall workflow, eliminating the need for a post-PCR ligation step, and reducing the potential for sample cross contamination. The per sample testing costs can be reduced by pooling samples from different LymphoTrack Dx Assays into a single sequencing run. The included bioinformatics software will sort the complex NGS data for easy analysis and visualization of individual samples. Detailed 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.com LymphoTrack® Dx IGHV Leader Somatic Hypermutation Assay 16 LymphoTrack® Dx IGH FR1/2/3 Assays 18 LymphoTrack® Dx IGH FR1/2/3 Assays Continued 20 LymphoTrack® Dx IGK Assays 22 LymphoTrack® Dx TRG Assays 24 LymphoTrack® Dx TRB Assay 26 LymphoTrack® Dx Bioinformatics Software 28 Determine clonality and track clonal populations with the same reagents and workflow. 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: 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 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) Assays