FDA advisers endorse Grail’s multi-cancer blood test
publishers 6articles 6first reported 23 Sep, 14:56 UTCdeveloping since 23 Sep · 4 editions
A U.S. Food and Drug Administration advisory committee has endorsed the benefits of Grail’s Galleri blood test in a key vote as the company seeks premarket approval, Reuters and The Wall Street Journal reported. The vote is an important step in the FDA’s review but does not amount to final agency approval.
Galleri is designed to look for signs of about 50 cancers from a single blood draw, including in people without symptoms. The test has drawn controversy over whether its performance supports broad screening of healthy patients.
MarketWatch reported that a major study failed to establish that Galleri could detect later-stage cancers. FDA approval could also affect whether Medicare and other health insurers cover the test.
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