CDx expertise to streamline your FDA approval

A gloved hand adds a sample to a tray full of vials.

Strategic regulatory consulting designed to match your specific CDx needs

Rapid technological advances and new precedents, including innovative trial designs and statistical analyses, are demanding an increased pace of new FDA regulatory guidance to ensure the development of safe and high-quality diagnostics. Our regulatory experts understand the unique and evolving landscape of companion diagnostics (CDx), and are at the center of  helping clients effectively and efficiently move from concept to market.

An expert in companion diagnostics development helps a professional plan at her computer.

Effective coordination and planning aimed at contemporaneous approvals

The CDx and therapeutic development interdependencies also means coordination is critical. Ideally, the need for a companion diagnostic is identified early in the therapeutic development process so that the validated CDx can be incorporated into the design of the therapeutic clinical trials. However, the need for a CDx may evolve at different points in the development of the therapeutic product. Moreover, differences in review may put at risk contemporaneous marketing authorizations. Submissions for therapeutics and biologics are reviewed by FDA (under standard or priority review timelines). In contrast, reviews of CDx PMAs can be less predictable.

Our team can provide detailed planning from diagnostic partner selection and early assay development considerations to strategies for bridging a clinical trial assay to submissions for a commercializable CDx. We offer end-to-end solutions to facilitate successful approvals and adopt an agile approach to equip our clients with the insight to make decisions and adapt to changes as your program evolves.

End-to-End CDx Solutions

Seamless support from feasibility through approval and beyond

With the benefit of our considerable experience in CDx and complementary diagnostic approvals, we offer guidance throughout the CDx co-development process. Our market-leading, co-development solutions will:

Support Feasibility

  • CDx partner selection, distribution model factors and platform selection
  • Diagnostics/Therapeutic co-development timeline development
  • Assay feasibility, proof of concept, and validation strategies
  • Quality management system considerations

Facilitate Development

  • Humanitarian use device (HUD), humanitarian device exemption (HDE), and breakthrough designation support
  • Early FDA (CDRH) engagement – pre-submission and pre-IDE planning
  • Significant risk (SR) and nonsignificant risk (NSR) determinations
  • Investigational device exemption (IDE) – submissions for use of SR devices in therapeutic trials and on-going IDE support
  • Abbreviated IDE requirements for use of NSR devices in therapeutic trials
  • CDx analytical testing requirements, protocol development and review
  • CDx clinical validation strategies – bridging studies and transfer of efficacy

Enable Approval

  • Regulatory approval strategies
  • Labeling considerations – claims
  • De novo development and submission
  • Pre-market approval (PMA) application development and submission
  • Bioresearch monitoring and manufacturing mock audit and inspection support
  • Post-market considerations