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Companion Diagnostics

In personalized and precision medicine, pharmaceuticals and diagnostics are rapidly becoming integrated. At Cerba Research, we support you and your patients through the expert development of companion diagnostics.

Simplify your strategy and co-develop your companion diagnostic early, along with your therapeutic agent.

A companion diagnostic test is an in vitro device that provides information related to the safety and efficacy of a specific therapeutic product. It can:

  • Identify patients most likely to benefit
  • Identify patients likely to be at increased risk for serious side effects
  • Monitor response to treatment, allowing adjustments for improved safety or effectiveness

Compiling the additional biomarker and genomic data needed to improve and speed decision making in oncology and, particularly, immuno-oncology, accelerates drug development. It may also improve approval rates: Drugs filed with companion diagnostics have a 30% rate of FDA approval, compared to 8% for those without.

Benefit from our experience developing IVD assays for use as CDx

  • We have a focus on IO, hematological cancers, and lung cancer
  • 60% of Cerba Research trials are in oncology
  • Better and more integrated access to both US and European markets is a critical need in oncology trials as they become more global and increase in cost and complexity

Implement regulatory-related best practices for the highest chance of swift approval for the combined therapy and companion diagnostic

  • Comply with the distinct regulations for both therapies and devices
    • Therapeutic Product: Investigational New Drug, 21 CFR 312
    • IVD: Investigational Device Exemption (IDE) Regulation, 21 CFR 812
  • Optimize clinical trial design to include investigation of IVD companion diagnostic along with the therapy
  • Ensure companion diagnostic is properly validated before trial starts to prevent issues later
    • CDx must be sufficiently analytically robust, particularly around the test’s clinical decision point(s)
    • Only use tests with “market-ready” performance in pivotal/Phase III trials
  • Gain expert assistance to ease the submission process for the therapeutic product and CDx

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Reach out to our experts and discover how we can help advance your research

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