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The case against FDA approval of Grail’s multicancer blood test
In a STAT opinion piece, cancer screening researcher H. Gilbert Welch says Grail’s trial missed its endpoint, yet an FDA advisory panel recommended approval.
TLDR
In a STAT opinion piece, cancer screening researcher H. Gilbert Welch argues that the FDA should not approve Grail’s multicancer blood test. He says a randomized trial involving 140,000 people failed to meet what he calls a suboptimal surrogate endpoint, yet an FDA advisory panel recommended approval. Welch warns that if the FDA approves the test, taxpayers could end up paying for it under a Medicare coverage law.
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