Health

Cancer blood test faces high-stakes FDA review

A blood test designed to spot signs of multiple cancers in apparently healthy people faces its first major regulatory hurdle Wednesday as advisers to the U.S. government review how well it works. Grail Inc.’s test looks for DNA fragments shed by tumor cells, an emerging…

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A blood test designed to spot signs of multiple cancers in apparently healthy people faces its first major regulatory hurdle Wednesday as advisers to the U.S. government review how well it works.

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Grail Inc.’s test looks for DNA fragments shed by tumor cells, an emerging approach to screening that aims to detect various cancers with a single blood draw.

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Cancer screening is supposed to spot tumors in their early stages, when they’re easier to treat. A multi-cancer screening test would be a departure from the handful of currently recommended cancer tests — including mammograms and colonoscopies — that look for one cancer at a time.

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A panel of Food and Drug Administration advisers will vote Wednesday on whether the proposed benefits of Grail’s Galleri test, designed for people 50 and older, outweigh risks such as missing cancers or causing false alarms.

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In documents posted ahead of the meeting, FDA staffers didn’t raise major safety concerns, but they want the panel to discuss whether the test picks up enough early stage cancers to be marketed for “early detection.”

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The FDA will weigh the advisers’ recommendations but is not required to follow them.

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People in the U.S. can already buy the test…

Original source: https://www.nbcnews.com/health

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