A panel of external experts advising the US Food and Drug Administration (FDA) has given cautious support to Grail's Galleri blood-based cancer detection test. The panel unanimously agreed on the test's safety, with all 10 members backing it. However, support for its effectiveness was narrower, receiving a 6-4 vote in favor. The panel further voted 7-2, with one abstention, that the test's benefits outweigh its risks.
The Galleri test, designed for adults aged 50 and older, screens for over 50 types of cancer from a single blood draw, a capability no other currently approved test in the US offers. The FDA is not bound by the panel's recommendations but typically weighs them heavily when making final decisions regarding product approvals. A final decision on whether Galleri can be sold nationwide is anticipated in the coming months.
While the test is currently available for purchase in the US, typically costing $700 or more out-of-pocket, FDA approval would significantly expand its availability by opening doors to coverage from Medicare and private insurers. Clinical trials, including a US study and a UK trial, showed the test detected cancers within 12 months with high specificity (99.85%) and rarely produced false alarms. However, concerns remain regarding its ability to detect enough early-stage cancers to be marketed for "early detection" and the potential for false positives leading to additional, potentially unnecessary, diagnostic tests.
