Companion Diagnostic Services

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.

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
  • GCP / CLIA compliance
  • A team of experts providing essential support that ensures timely delivery of project milestones
  • 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
  • Global regulatory expertise in key regions, including but not limited to US FDA, Japan MHLW, and China FDA
  • Strict quality control systems
  • Part of the Sysmex family, a top 10 IVD company with commercial activities in 175+ countries

 

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.

Sysmex Inostics Provides

  • Biomarker assay development
  • Analytical validation
  • Clinical validation
  • Kit development
  • Regulatory registration/approval (510k, PMA, CFDA, CE)
  • cGMP manufacturing
  • GCP/CLIA certified testing services
  • Project management
  • Commercialization

More Information

  1. Papadopoulos et al. Nat Biotechnol. Aug;24(8):985-95 (2006)
  2.  Draft Guidance for Industry and FDA Staff – In Vitro Companion Diagnostic Devices
  3.  Critical Path Initiative of the FDA

Biomarker Assay Development

OncoBEAM™ Mutation Testing

BEAMing Technology fact sheet

Factsheet Companion Diagnostics

OncoBEAM™ FAQs

For Pharmaceutical/CRO Testing Services

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