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US FDA Oncology Diagnostics Pilot Is ‘Interim Step’ To Fill VALID Void, But ‘Stuck In Neutral’

 
• By Kate Rawson

Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.

hand-dropping-chemical
• Source: Shutterstock

While the US Food & Drug Administration navigates the process of finalizing its proposed rule on laboratory-developed tests – and the legal challenges that are sure to follow – FDA sees other internal programs, like the recently launched oncology diagnostics pilot, as a way to ensure the reliability and accuracy of diagnostic tests. But it needs sponsors to sign up.

Key Takeaways

  • Sponsors may not be joining FDA’s pilot because they are unaware which test was used in their studies, or their lab testing partners are unwilling to share their data.

  • Legislation will likely be required for comprehensive reform of lab-developed test oversight

The agency announced the voluntary oncology pilot program via 

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