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Product Catalog Personalized Molecular Medicine ® 2018 Standardized solutions for the diagnosis, PRODUCT stratification, monitoring & study of oncology CATALOG Industry Pioneers We pride ourselves on staying at the forefront of new technologies. We oer a full range of standardized CE-marked in vitro diagnostic products for detection of hematological malignancies, as well as RUO assays, analyte specific reagents, and nucleic acid controls. Letter to Our Colleagues Our LymphoTrack® Dx and LymphoTrack® Assays for use on both the Illumina® MiSeq® and Thermo Fisher Scientific® Ion PGM™ instruments can be used to identify clonal lymphocyte populations, track minimal residual disease, and evaluate the status of somatic hypermutation Dear Colleagues: using our comprehensive, easy-to-use bioinformatics software. I am pleased to introduce our 2018 Product Catalog and I would like to take this opportunity to share some 2017 developments and Our CE-IVD gold-standard B- and T-cell PCR-based gel and capillary testing reagents, developed under ISO 13485 design control, are future plans at Invivoscribe. standardized, molecular hematopathology products that reduce discordance between laboratories and increase sensitivity and specificity. In April of 2017 we received FDA approval of our PMA for the LeukoStrat® CDx FLT3 Mutation Assay, a companion diagnostic that aids in the selection of patients with AML for whom midostaurin treatment is being considered. We were pleased to see successful culmination of the work we did for our partner, Novartis, and confirmation of the capabilities of our excellent team. In addition, Global Reach we have now validated and released a CE-marked IVD version of this assay for use outside North America (page 62), and we are The Invivoscribe portfolio of cGMP products are currently being used by more than 700 clinical and research laboratories across 105 working towards FDA approval of a distributable version of this assay, so that we can oer it as a kitted product to our customers countries worldwide. here in the US. In 2017 we also released the LymphoTrack® TRB Assay. We now provide a comprehensive menu of LymphoTrack® Clonality Assays along with comprehensive interpretative LymphoTrack® software for the MiSeq® next-generation sequencing (NGS) platform (page 20). We will release our TRB Assay for Thermo Fisher® NGS platforms later this year. LymphoTrack® assays are used to identify and track clonal rearrangements within the antigen receptor loci (IGH, IGK, TRG, TRB). The 24 ID format allows customers to significantly reduce costs, as you can run any combination of the 7 assays (up to 154 samples and 14 controls) simultaneously, while the accompanying bioinformatics software automatically sorts and interprets the data for each targeted region and sequence ID. Our team has enjoyed significant satisfaction in seeing our Research Use Only (RUO) assays being used in research and clinical trials in the US, and our CE-marked IVD versions of the assays being used by leading cancer centers abroad. These assays assist in the diagnosis and tracking of a wide variety of hematologic malignancies, and they are also used to evaluate somatic hypermutation (SHM) in chronic lymphocytic leukemia (CLL). In fact, a group at Oxford has already published a paper in Leukemia, describing use of Invivoscribe, Inc. our IGHV SHM Assay and our LymphoTrack® bioinformatics software in order to update prognostic stratification of patients with CLL. San Diego, CA, USA These clonality assays will be submitted for review via the US FDA’s 510(k) process. Additionally, our LymphoTrack® assays are also being used in concert with accompanying minimal residual disease (MRD) bioinformatics software, for the study of MRD in a wide LabPMM LLC range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. San Diego, CA, USA Our number of international clinical trials have expanded for one of our other pharmaceutical partners, Astellas, and we developed, validated and have started monitoring clinical trial subjects using our internationally standardized and CLIA/CAP-listed FLT3-ITD MRD assay that may be up to two logs more sensitive than other FLT3 assays. These MRD assays and bioinformatics software are being used as a tool to support clinical validation endpoints in drug development studies for a number of pharmaceutical partners. We expect a paper describing the use of this assay to be published soon. In our continuing eorts towards achieving international harmonization of molecular diagnostic testing, we are developing and will soon release a series of LymphoQuant™ MRD controls that can be used as internal spike-in controls with all of our MRD assays to help leading cancer research centers quantify residual disease. Further, our LymphoTrack® assays identify many CAR-T and engineered T cell constructs, so in a research or clinical trial setting they can be used throughout treatment to simultaneously identify and track both the subject’s immune response and levels of immuno-therapy constructs. To accommodate our rapid growth, Invivoscribe has moved into a brand-new, custom-designed facility in San Diego, more than doubling our previous company headquarter’s space. We increased sta£ng in our San Diego (USA) and Martinsried (Germany) ISO 15189 accredited clinical laboratories, allowing us to provide clinical testing services 6 days a week. We set up a clinical laboratory in Japan, where we have started clinical testing and enrollment of subjects for clinical trials. In addition, we also opened an o£ce in Shanghai (Invivoscribe Diagnostic Technology Co. Ltd.), to support clinical trials in China. We have also expanded our NGS portfolio, developing and launching several NGS-based panels, including MRD testing for a number of hematologic biomarkers. Our MyAML®, MyMRD™, and MyHeme® gene panels, combined with our custom bioinformatics pipeline, MyInformatics™, are oered as RUO only and/or as CLIA/CAP-listed tests through our clinical laboratories in the USA, Invivoscribe, SARL Europe and Asia. La Ciotat, FR Our continued growth and progress would not be possible without your constant feedback and support. We look forward to LabPMM GmbH continuing our interaction with the research and clinical communities so we can oer you the best molecular products for decades to Munich, DE come. We wish you, your colleagues, and your families a joyful, productive, and successful 2018. Sincerely Yours, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd. Shanghai, CN Jerey E. Miller, PhD LabPMM GK Founder, Chief Scientific & Chief Executive O£cer, and Chairman Tokyo, JP Table of Contents Introduction T-Cell Receptor Gamma Gene Rearrangement Assays 90 TCRG Gene Clonality Assays 92 Letter to Our Colleagues 1 TCRD Gene Clonality Assays 94 BCL1/JH Translocation Assay 96 Background BCL2/JH t(14;18) Translocation Assay 98 Introduction 4 BCL2/JH Translocation Assay 100 Test Algorithm for Suspect Lymphoproliferations 5 BCR/ABL t(9;22) Translocation Assays 102 PML/RARa t(15;17) Translocation Assays 104 Next-Generation Sequencing (NGS) IGH Somatic Hypermutation Assays v2.0 106 FLT3 Mutation Assays 108 LymphoTrack® Dx Assays 6 LymphoTrack Dx IGHV Leader Somatic Hypermutation Assay 8 Analyte Specific Reagents LymphoTrack Dx IGH FR1/2/3 Assays 10 LymphoTrack Dx IGK Assays 14 Analyte Specific Reagents 110 LymphoTrack Dx TRG Assays 16 LymphoTrack Dx TRB Assays 18 Controls LymphoTrack Dx Bioinformatics Software 20 Overview 112 DNA Controls 114 LymphoTrack® Assays Research Use Only (RUO) 22 RNA Controls 118 LymphoTrack IGHV Leader Somatic Hypermutation Assay 24 Control Panels 122 LymphoTrack IGH FR1/FR2/FR3 Assays 26 Master Mix Controls 124 LymphoTrack IGK Assays 30 Reagents 125 LymphoTrack TRG Assays 32 Enzymes 125 LymphoTrack TRB Assays 34 LymphoTrack Bioinformatics Software 36 Custom Products LymphoTrack Bioinformatics Software 38 Custom Products 126 Gel and Capillary Services: NGS Cancer Panels 128 TM IdentiClone Assays 40 MyAML® 130 IGH + IGK B-Cell Clonality Assays 42 MyHEME® 132 IGH Gene Clonality Assays 44 MyMRD™ 134 IGK Gene Clonality Assays 46 IGL Gene Clonality Assays 48 Reference 136 TCRB + TCRG T-Cell Clonality Assays 50 Clonality Testing Workflow Methods 137 TCRB Gene Clonality Assays 52 Illumina® MiSeq® Workflow Summary 138 T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 54 Thermo Fisher Scientific® Ion PGM™ Workflow Summary 139 TCRG Gene Clonality Assays 56 Next-Generation Sequencing Menu 140 TCRD Gene Clonality Assays 58 Gel and Capillary Electrophoresis Menu 141 BCL1/JH Translocation Assay 60 Hematologic Malignancy Research and Testing Guide 142 BCL2/JH Translocation Assay 62 Common Technical Support Questions 143 Recent Poster Abstracts 146 LeukoStrat® Assays 64 FLT3 Mutation Assay - Gel 66 Product List FLT3 Mutation Assay 2.0 - ABI Fluorescence 68 Product List by Catalog Number 148 CDx FLT3 Mutation Assay 70 Index Research Use Only (RUO) Assays 72 Alphabetical Index 152 IGH + IGK B-Cell Clonality Assays 74 IGH Gene Rearrangement Assays 76 IGH Gene Clonality Assays 78 IGK Gene Clonality Assays 80 IGL Gene Clonality Assays 82 TCRB + TCRG T-Cell Clonality Assays 84 TCRB Gene Clonality Assays 86 T-Cell Receptor Gamma Gene Rearrangement Assay 2.0 88 2 Background Test Algorithm for Suspect Lymphoproliferations Developed in concert with the EuroClonality/BIOMED-2 group for PCR-based clonality assessment of suspected B- and T-cell lymphoproliferative disorders. If a definitive diagnosis is not possible following: Morphology Immunohistochemistry Flow Cytometry PCR & NGS-Based
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