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