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FDA panel narrowly backs multi-cancer blood test despite doubts it works

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FDA panel narrowly backs multi-cancer blood test despite doubts it works

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A blood test that aims to catch more than 50 types of cancer before symptoms appear narrowly won the backing of U.S. Food and Drug Administration (FDA) advisers Wednesday, even as several doubted it works.

The test, called Galleri, looks for bits of DNA in the blood that may signal cancer. Its maker, Grail, says it can spot cancers of the stomach, bladder, colon, skin and breast, among others, The Washington Post reported.

Galleri has been sold in the United States since 2021 without FDA approval and costs nearly $1,000. Grail applied for approval in February and says the test, meant for adults 50 and older, shouldn't replace standard screenings.

The FDA's 10-member advisory committee declared in a 6–4 vote that the test is effective.

On whether its benefits outweigh its risks, members voted 7–2, with one abstention. All agreed it's safe.

Some members said finding cancers that have no screening option today made the test worth backing, but others voted yes with reservations, The Post reported.

"If we can find more stage 1 or more early-stage cancers in a population that we can't screen for currently, then that will end up having benefit," said committee member Dr. Victor van Berkel, division chief of thoracic surgery at the University of Louisville in Kentucky. "But I don't know that that's been proven yet.



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