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
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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.
The agency announced the voluntary oncology pilot program via final guidance last summer as a stop-gap measure to...