Food and Drug Administration reviewers have no outstanding questions for an advisory panel about the primary safety analysis or laboratory performance of GRAIL's Galleri multi-cancer blood test, according to an FDA executive summary posted ahead of Wednesday's meeting. The same document shows the test flagged only about one in three cancers diagnosed within a year of a blood draw, and far fewer of the earliest-stage tumors.
That second finding matters most for adults 50 and older who already buy the test by prescription. An earlier version has been available in the United States since 2021. A "No Cancer Signal Detected" result can feel like a clean bill of health, but the agency's numbers show most cancers found during follow-up were not flagged in advance.
