FDA advisory panel recommends approval of Grail multi-cancer blood test

The short version

• An FDA advisory panel voted 7 to 2, with one abstention, that the benefits of Grail's Galleri cancer blood test outweigh its risks for indicated patients.[STAT]
• The panel unanimously deemed the multi-cancer screening test safe and voted 6 to 4 that there is reasonable assurance of its effectiveness.[STAT]
• The blood test is already available out of pocket in the United States for $700 or more under regulatory provisions for laboratory tests.[ABC News]
• The FDA will make the final decision on whether to approve the test, as it is not mandated to follow panel findings.[STAT]

Key facts

• The FDA advisory committee voted 10 to 0 on safety, 6 to 4 on effectiveness, and 7 to 2 with one abstention that benefits outweigh risks for patients meeting proposed indications.[STAT]
• The FDA often adopts advisory panel recommendations but is not required by law to do so.[STAT]
• In the United States, patients can currently buy the test for $700 or more out of pocket under rules governing certain laboratory-developed tests.[ABC News]
• Data released by the FDA showed the test accurately predicted cancer in more than 66 percent of patients who had a cancer signal detected.[ABC News]
• During a one-year window, the test identified approximately 30 percent of the cancers that were subsequently diagnosed by physicians.[ABC News]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.

• Grail's cancer blood test faces high-stakes FDA reviewABC News - US News
• STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risksSTAT metered