FDA Panel Backs Grail Cancer Test That Failed Trial — SkimNews
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- Grail's 140,000-person NHS trial of its multicancer blood test failed to meet its primary surrogate endpoint — a reduction in late-stage cancer diagnoses — yet an FDA advisory panel recommended the test for approval.
- The trial used late-stage cancer incidence as a surrogate rather than cancer death, the gold standard for screening evaluation, even though Grail's own investigators had modeled a potential 25% reduction in all-cancer mortality.
- The Medicare Multi-Cancer Early Detection Screening Coverage Act, signed into law earlier this year, mandates Medicare coverage of multicancer screening tests upon FDA approval, bypassing the usual U.S. Preventive Services Task Force review.
- Grail has been sued by its own investors twice (2024 and 2026), and former UK Prime Minister David Cameron served as a paid adviser while the NHS hosted the high-profile 140,000-person trial.
- H. Gilbert Welch estimates annual screening of all Americans 50 and older would cost $60-$100 billion per year, based on 120 million eligible adults and a test price between $500 (Medicare's Cologuard benchmark) and $949 (Grail's list price).
- The National Cancer Institute is preparing a major randomized trial of multicancer screening using cancer death as the endpoint, which Welch warns could be undermined if Grail's test is already approved and covered by insurance.
Why it matters: If the FDA approves Grail's test, the Medicare MCED Coverage Act would force automatic coverage — and the author's $60–$100 billion annual cost estimate for screening Americans 50+ could hit taxpayers before the National Cancer Institute completes a properly designed mortality trial that would actually determine whether the test saves lives.
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