b'MRD testing by Next-GenerationSequencing (NGS) is a proven tool in the Minimal Residual Disease (MRD) Solution development of management strategiesfor hematologic malignancies.Key BenefitsComplete solution for MRD clonality A number of investigators have described NGS-based approaches that have demonstrated success in detecting and monitoring MRD in Chronic Ensures test sensitivity to enable confidence in reportingLymphocytic Leukemia (CLL), Acute Lymphoblastic Leukemia (ALL) and other lymphoid malignancies. 1,2LymphoTrack Assays are NGS-based deep sequencing Facilitates standardization of clonotype trackingLymphoTrack MRD Software for automated analyses with PDF Reports assays that detect virtually all clonal rearrangements within targeted T-cell Longitudinal assessment of mutation status of IGH and T-cell clonality including receptor (TCR) or immunoglobulin (Ig) antigen receptor loci. Once a specificgene rearrangements and somatic hypermutation (SHM) rearrangement (the clonotype) has been identified, LymphoTrack assays can LymphoTrack Assays formatted for both Illumina and Thermo Fisher NGS Platforms available 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 56/ LymphoTrack Minimal Residual59/ LymphoQuant B-cell & T-celland tracking of rearrangement (clonotype) sequences.Disease (MRD) Software Internal ControlLymphoTrack MRD bundles offer a complete MRD solution for clonality tracking. IGH or T-cell bundles may be purchased that include the 58/ LymphoTrack B-cell & T-cellLymphoTrack Assay, LymphoTrack MRD Bioinformatics Software, a LymphoTrack Low Positive Control and a LymphoQuant Internal Control. Low Positive ControlsEach 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 may aid in the early detection of WARRANTY AND LIABILITY 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 Invivoscribe (Invivoscribe) is committed to providing the highest quality products. Invivoscribe warrants that the products meet or exceed the performance standards described in theLymphoTrack Low Positive Control confirms the sensitivity of respective LymphoTrack MRD runs match or exceed a10 -4(or 1 in 10,000) level. 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-4 Detection of the LymphoTrack Low Positive Control thus lessens false negative reporting concerns at 10 , and is further necessary to report full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe . Invivoscribeliability shall not exceed the purchase price of the product. Invivoscribeshall 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 controlledMRD negative results with confidence at 10 -4 .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 purchaserConsistent use of a spike-in internal control promotes objective monitoring of clonality over time enabling test standardization.agreement to the limitation of liability set forth in this paragraph. To serve this need, Invivoscribe offers a LymphoQuant B-cell and T-cell Internal Control. Addition of a spike-in LymphoQuant B-cell or T-cell NOTICE:Many uses 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 toInternal Control to samples allows for the estimation of clonotype cell equivalents to facilitate longitudinal clonotype tracking over time.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, amplification 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.References:1Leukemia 27:1659-1665, 2013.2Blood 120:5173-5180, 2012. 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. Invivoscribe 2021|55'