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Companion Diagnostic Services www.sysmex-inostics.com A Single-Source Partner to Pharmaceutical Companies for a Full Spectrum of Companion Diagnostic Services Sysmex Inostics develops and commercializes innovative, blood-based diagnostic tests. We are a trusted partner to leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies to global markets. Collaborative Approach Sysmex Inostics is a strategic partner to pharmaceutical companies. Our scientific expertise—combined with legal, regulatory, product launch, marketing, and physician education capabilities—creates the foundation for successful commercialization of companion diagnostic products. In this way, Sysmex Inostics together with our pharmaceutical partners have measurable impact on the delivery of personalized medicine to growing numbers of patients around the world. Our Proven Ability to Deliver Meeting the many challenges inherent in cancer drug development is the constant focus of Sysmex Inostics. Our pharmaceutical clients can depend on: Broad-based services -Feasibility studies -Clinical validation -Custom companion diagnostic development -Commercialization of kits to global markets PHAMACEUTICAL PARTNERS n n SALES & MARKETING CHANNELS ASSAY DEVELOPMENT GCP / CLIA compliance Sysmex Inostics n A team of experts providing essential support that ensures timely delivery of project milestones n Gold-standard OncoBEAM™ technology, a blood-based mutation assay that requires no tissue -Non-invasive specimen collection, supporting high enrollment and patient compliance -Sensitive detection of rare cancer gene mutations - Support patient stratification for more efficient clinical studies and trials -Highly sensitive, real-time assessment of tumor status n Global regulatory expertise in key regions, including but not limited to US FDA, Japan MHLW, and China FDA n Strict quality control systems n Part of the Sysmex family, a top 10 IVD company with commercial activities in 175+ countries cGMP MANUFACTURING REIMBURSEMENT REGULATORY APPROVALS Sysmex Inostics Provides n Biomarker assay development n Analytical validation n Clinical validation n Kit development n Regulatory registration/ approval (510k, PMA, CFDA, CE) CLINICAL TRIALS n cGMP manufacturing GCP/CLIA certified testing services n Project management n Commercialization n Sysmex Inostics is a molecular diagnostics company that provides testing for research and cancer drug development companies, as well as clinical testing for physicians. The company offers highly sensitive assays that detect mutations from plasma and serum samples. We serve clients around the world from our offices and laboratories in the United States, Germany, China, and Japan. To learn how Sysmex Inostics can advance cancer drug development in your organization, please call 1-855-BEAM-DNA (232-6362). Sysmex Inostics GmbH Falkenried 88, 20251 Hamburg, Germany · Phone +49 40 413383-90 · Fax +49 40 413383-99 · [email protected] · www.sysmex-inostics.com Sysmex Inostics, Inc. One Nelson C. White Parkway, Mundelein, Illinois 60060, USA · Phone Toll-Free: +1-855-BEAM-DNA (232-6362) · [email protected] · www.sysmex-inostics.com Sysmex Corporation 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan · Phone +81 78 265-0500 · Fax +81 78 265-0524 · www.sysmex.co.jp CDX.EN.N.8/14 © Copyright 2014 – Sysmex Inostics GmbH