CDx Development and Commercialisation

CDx Development and Commercialisation

Multiplex companion diagnostics provide a proven means of capturing complex biology and will change the way medicines are developed, regulated and prescribed. We are uniquely placed to partner with clients throughout the entire process of MCDx development – from the fundamental research and discovery phase, through the conduct of clinical trials and the manufacturing of test kits, to the patient sample testing.Our scientists are experts in a wide range of scientific disciplines and have experience in working with FFPE tissue as well as fresh tissue. They are supported by teams of experts in disciplines such as bioinformatics, biostatistics, molecular biology, pathology, product development and quality/regulatory control. As a major global company, we have the financial stability to stand alongside our customers. We also have the organisational and logistical resources necessary to provide an end-to-end service, which can be scaled out to every major market from our clinical laboratory hubs in the USA, Europe and APAC.

 

CDx Experience

  • CDx experience in a range of diseases
    • Oncology:
      Breast | Lung | Colon | Bladder | Gastric | Ovarian
    • Immunology:
      Rheumatoid arthritis | Ulcerative colitis | Crohn’s disease
  • Multiple drug classes supported
  • RNA and DNA based multiplex tests
  • Extensive regulatory experience
    FDA | MHRA | EMEA | Japan | Partnerships in China

 

Our CDx Solutions

CDx Development
  • Design control and risk management
  • Sample Sourcing
  • Assay Development and validation
  • Assay Software Development
  • Manufacturing
  • Regulatory submissions
  • Registrational trial testing (IDE)

 

CDx Commercialisation
  • Full single source laboratory (LDT-PMA) commercialisation
  • IVD kit commercialisation
  • Flexible platforms
  • Global clinical testing laboratories
  • Partnerships in Asia




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