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FDA advisory panel to vote on a multi-cancer blood test : NPR
NPR • • business
Key Points:
- The FDA advisory committee is set to vote on approving Grail's Galleri blood test, which detects up to 50 types of cancer, many not routinely screened for, potentially marking the first FDA-approved multi-cancer blood test.
- Approval could lead to insurance coverage, with the test currently priced at $949, and the FDA expedited its review following Medicare coverage approval for multi-cancer detection tests.
- Clinical studies involving over 175,000 patients showed Galleri did not meet primary endpoints like overall mortality reduction, but data suggested a decrease in Stage IV cancer diagnoses, indicating possible earlier detection.
- Experts note that the studies' short duration limits conclusions on mortality benefits, but view the test as promising for early cancer detection and expect FDA approval based on the totality of evidence.
- The Galleri test is intended to complement, not replace, standard screenings and could significantly impact cancers lacking current screening methods, addressing a major need in oncology.
