An FDA advisory panel voted to endorse Galleri, a blood test by Grail for screening multiple cancer types, determining that benefits outweigh risks. The panel voted unanimously on safety and by majority on effectiveness and overall benefit-risk profile. The FDA is not required to follow the panel's recommendation but typically does.
An FDA panel voted in favor of Grail's Galleri blood test, which screens asymptomatic patients for multiple cancers. The mixed vote represents a key step toward FDA approval for the early cancer detection technology.
An FDA advisory committee will vote today on whether to recommend approval of Galleri, a multi-cancer blood test made by Grail that claims to detect up to 50 cancer types. The decision could lead to insurance coverage for the $949 test and validate the emerging field of blood-based cancer screening, though the test did not meet its primary endpoints in clinical trials.