Summary
This white paper provides a comprehensive overview of Companion Diagnostic (CDx) development, emphasizing its critical role in precision medicine and oncology drug approval. It details the co-development process where a therapeutic and its corresponding diagnostic test are developed simultaneously to identify patients most likely to benefit from a specific treatment. The paper outlines the technical and regulatory journey from biomarker discovery and analytical validation to clinical trial integration and FDA submission. Furthermore, it highlights the shift toward Next-Generation Sequencing (NGS) and the strategic importance of choosing the right diagnostic partner to mitigate risks and accelerate the path to market.
In this white paper, you will learn the following:
- Double Your Approval Odds: Learn how biomarker strategies can increase oncology therapeutic approval rates by twofold, as seen in 60% of 2024 FDA approvals.
- Streamline CDx Development: Discover proven strategies for selecting lab and IVD partners to accelerate development from phase 1 to market.
- Navigate Complex Regulations: Gain clarity on FDA and EU IVDR requirements to ensure compliance and minimize regulatory risks.
Discovery Life Sciences has supported over 2,000 clinical studies, including 50+ CDx programs, leveraging cutting-edge technologies like NGS, IHC and PCR.
Ready to advance your CDx program? Schedule a consultation with our experts today.
From the Author
About the Author
Scott Reid, PhD, MBA, Vice President and Global Head of Companion Diagnostics at Discovery Life Sciences, brings 25 years of drug development expertise. With experience at SOPHiA Genetics and NeoGenomics, Scott leads innovative CDx solutions for global clinical trials.