An FDA panel splits on Galleri and does not approve it
A U.S. Food and Drug Administration advisory panel voted 10-0 that Grail's Galleri blood test is safe, 6-4 on effectiveness and 7-2 with 1 abstention on whether benefits outweigh risks. The panel is not an approval. Medical Daily reported the 7-2 benefit vote and the 6-4 effectiveness split for adults 50 and older.
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The panel voted 10-0 on safety
A U.S. Food and Drug Administration advisory panel accepted the safety of Grail's Galleri blood test 10-0, split 6 in favour to 4 against on effectiveness, and voted 7 in favour to 2 against with 1 abstention on whether benefits outweigh risks. The panel is not an approval. No multi-cancer early detection test has FDA approval yet. Medical Daily reported that the panel voted 7-2 that the Galleri cancer blood test's benefits outweigh its risks, but split 6-4 on effectiveness, for adults 50 and older.[1], [2]
The test is designed for people aged 50 and over
Scientific American says the test is designed for people 50 and over and that a negative result leaves cancer possible. Goel called the vote an encouraging step rather than the final word on clinical value. The same account says no multi-cancer early detection test has FDA approval yet. The panel's tally is 10-0 on safety, 6-4 on effectiveness and 7-2 with 1 abstention on benefit, for adults 50 and over. Medical Daily also reports the 6-4 effectiveness split and the 7-2 benefit vote.[1]
The FDA has not yet approved the test
Scientific American holds the full tally, including the 10-0 safety vote and the Nature Medicine figures. Medical Daily holds the 7-2 benefit vote and the 6-4 effectiveness split, and it places both questions with adults 50 and older. The shared point is that an advisory panel voted and the agency has not approved the test. Scientific American also records that the panel accepted safety 10-0, split 6 in favour to 4 against on effectiveness, and voted 7 in favour to 2 against with 1 abstention on benefit. Medical Daily places the 7-2 benefit vote and the 6-4 effectiveness split with adults 50 and older. The agency has not approved a multi-cancer early detection test. Goel called the advisory vote an encouraging step rather than the final word on clinical value. A negative result leaves open the chance that cancer is present. The test is designed for people 50 and over. Those sentences are the vote and its limit, not a claim that clinics should replace existing screening.[1], [2]
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