An FDA advisory committee reviewed Grail’s Galleri blood test, which is intended to screen adults 50 and older for signals associated with more than 50 cancers.
The central effectiveness issue was whether Galleri finds enough cancers at early stages to support an “early detection” indication. FDA materials reportedly asked advisers to address that question despite not identifying major analytical-performance or safety concerns.
In FDA-released study data, Galleri correctly predicted cancer in more than 66% of people who received a positive cancer-signal result, but detected only about 30% of cancers subsequently diagnosed over one year—highlighting the risk of missed cancers.
A large U.K. NHS-Galleri study did not meet its primary endpoint of a statistically significant reduction in combined stage III and IV cancer diagnoses over three years. No trial has yet shown that Galleri reduces cancer mortality.
Key risks discussed include false positives leading to follow-up testing and anxiety, and false negatives creating false reassurance. The test is not meant to replace established screening for breast, colorectal, lung, cervical, or other guideline-covered cancers.
The advisory panel’s recommendation is nonbinding; the FDA will make the final decision on Grail’s premarket-approval application.
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