The panel will review Grail's request for premarket approval, the Food and Drug Administration's most stringent review process for medical devices. The agency is not required to follow the panel's recommendation.
The test, along with Abbott Laboratories' (ABT.N) Cancerguard, is already available on the market, but neither is FDA-approved. Both are offered as laboratory-developed tests under Clinical Laboratory Improvement Amendments regulations, which means doctors can order them.
A January U.S. congressional funding bill, however, created a pathway for Medicare coverage of FDA-approved multi-cancer early detection (MCED) tests for individuals aged 50 to 65 from 2029, subject to clinical benefit, but analysts have questioned Galleri's reimbursement prospects.
MCED tests analyze molecular signals shed by tumors into the bloodstream from a single blood draw. AI and machine learning algorithms then interpret these signals to detect potential cancers and, in many cases, predict their tissue of origin.
Grail said it submitted its regulatory application for Galleri on January 29, which included findings from a U.S. study of 25,490 people tracked for one year and from the first year of a UK study of more than 70,000 people.
The test screens for signals of more than 50 cancers from a single blood sample and is meant to complement, not replace, established screenings such as mammograms and colonoscopies.
