An advisory committee to the U.S. Food and Drug Administration (FDA) voted 7-2 in favor of GRAIL’s premarket approval application for its Galleri multi-cancer early detection (MCED) test. The panel concluded that the test’s benefits outweigh its potential risks for screening adults aged 50 and older.
The review marks the first time an FDA advisory panel has assessed an MCED test. Galleri uses a blood draw to look for a shared cancer signal across more than 50 types of cancer. The panel’s recommendation followed its evaluation of the test’s safety, clinical effectiveness and overall benefit-risk balance.
The FDA is not required to follow its advisory committees’ recommendations, though it typically does. A final approval could significantly affect cancer diagnostics and create a substantial market opportunity for GRAIL. The panel’s vote is also relevant to investors in genomics and diagnostic-focused ETFs, as it points to a potential shift toward earlier cancer detection.