An FDA advisory panel voted to endorse Grail’s multi-cancer blood test, Galleri, concluding that the benefits outweigh the risks for adults meeting the proposed indication. The panel voted unanimously that the test is safe, while effectiveness votes fell closer on the risk-benefit balance. The decision represents an important procedural step for multi-cancer early detection, which has lacked an FDA-approved product as a class. In earlier Nature Medicine results involving more than 35,000 participants, Galleri detected signals in a subset later diagnosed with cancer and showed high specificity. FDA is not required to follow the panel’s recommendation, but the vote heightens the likelihood of an FDA decision moving toward a definitive regulatory outcome.
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