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- FDA moves to reclassify diagnostic tests
The CAP has submitted comments in response to the FDA’s reclassification of nucleic acid-based test systems.
What we're saying: In our January 26 letter, we expressed support for the FDA's move to reclassify nucleic acid-based oncology tests. We also encourage the agency to consider reclassifying IHC and ISH tests.
Dive in: This reclassification is vital as it broadens access to diagnostic tests across the US, enhancing cancer care. The reclassification acknowledges the reliability of longstanding technologies used in these tests.
Our comments emphasize the importance of transparency in the FDA's processes, fostering trust between pathologists and patients.
- The CAP advocates for sufficient labeling of tests to aid pathologists in setting benchmarks for performance.
- This involves collaboration with drug and test developers to ensure comprehensive device labeling.
What's next: The CAP is open to assisting the FDA in reclassifying other diagnostic methods.