Invivoscribe 2019 | 47 NGS RUO Assays 46 LymphoTrack MRD B-cell and T-cell bundles offer a complete MRD solution for clonality tracking. B- or T-cell bundles may be purchased that include the LymphoTrack Assay, LymphoTrack MRD Bioinformatics Software, a LymphoTrack Low Positive Control and a LymphoQuant Internal Control. Each bundle facilitates the standardization of MRD testing by providing controls suitable for longitudinal MRD tracking with test sensitivity assurance. LymphoTrack MRD Software further simplifies clonal tracking due to rich sequence specific data analyses. This software enables longitudinal monitoring of clonal populations by providing multiple functionalities to the user including project planning features and automated bioinformatics applications. When monitoring MRD, a highly sensitive detection method such as NGS-based LymphoTrack facilitates the early detection of lymphoproliferative disease relapse. However, MRD test results are dependent on DNA amounts interrogated, as well as the confidence level of the test. Controls tracking MRD test sensitivity are thus necessary when reporting MRD test results. Designed for MRD testing, the LymphoTrack Low Positive Control confirms the sensitivity of respective LymphoTrack MRD runs match or exceed a 10-4 (or 1 in 10,000) level. Detection of the LymphoTrack Low Positive Control thus lessens false negative reporting concerns at 10-4 , and is further necessary to report MRD negative results with confidence at 10-4 . Consistent use of a spike-in internal control promotes objective monitoring of clonality over time enabling test standardization. To serve this need, Invivoscribe includes a LymphoQuant B-cell or T-cell Internal Control in each bundle. Addition of a spike-in LymphoQuant B-cell or T-cell Internal Control to samples allows for the estimation of clonotype cell equivalents to facilitate longitudinal clonotype tracking over time. LymphoTrack Minimal Residual Disease (MRD) Software  48 LymphoTrack B-cell & T-cell Low Positive Controls  50 LymphoQuant B-cell & T-cell Internal Control  51 Introducing the LymphoTrack Minimal Residual Disease (MRD) Solution Research Use Only (RUO) MRD testing by Next-Generation Sequencing (NGS) is a proven tool in the development of management strategies for hematologic malignancies. A number of investigators have described NGS-based approaches that have demonstrated success in detecting and monitoring MRD in Chronic Lymphocytic Leukemia (CLL), Acute Lymphoblastic Leukemia (ALL) and other lymphoid malignancies.1,2 LymphoTrack Assays are NGS-based deep sequencing assays that detect virtually all clonal rearrangement within targeted T-cell receptor (TCR) or immunoglobulin (Ig) antigen receptor loci. Once a specific rearrangement (the clonotype) has been identified, LymphoTrack assays can be used to track these clonotype populations to a sensitivity as low as 10-6 . Complementing the LymphoTrack Assays, the LymphoTrack MRD solution is a bundled product set for improved Minimal Residual Disease (MRD) assessment and tracking of rearrangement (clonotype) sequences. Key Benefits Complete solution for MRD clonality testing includes controls and software Ensures test sensitivity to enable confidence in reporting Facilitates standardization of clonotype tracking LymphoTrack MRD Software for automated analyses with PDF Reports Longitudinal assessment of mutation status of B- and T-cell clonality including gene rearrangements and somatic hypermutation (SHM) LymphoTrack Assays formatted for either Illumina® or Thermo Fisher NGS Platforms Minimal Residual Disease (MRD) Solution 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. Change Tab References: 1Leukemia 27:1659-1665, 2013. 2Blood 120:5173-5180, 2012. MRD RUO Assays