Companion Diagnostics Guidance Needs Clarity on Product Coverage, Industry Commenters Say

Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments on the draft.

Companion diagnostics are on the rise, the Pharmaceutical Research and Manufacturers of America (PhRMA) observed in its comments to the FDA. Nearly 30 drugs and biologics with an IVD companion diagnostic have been approved as of June of this year, with many more under development by biopharmaceutical companies, wrote Kristin Dolinski, PhRMA’s director for science and regulatory advocacy.

“Therefore, it is critical that both biopharmaceutical and diagnostic sponsors have a clear and predictable pathway for the development and regulatory review of such products,” she indicated.