An advisory panel to the U.S. Food and Drug Administration recommended that Grail’s Galleri blood test move closer to approval, saying its potential benefits outweigh its risks. The FDA is not required to follow the recommendation, although it often does, and Wall Street analysts expect a decision favoring Grail in the coming months. Approval could help the test qualify for Medicare coverage from 2028 under a U.S. law passed this year and strengthen the case for private insurance reimbursement. Galleri and Abbott’s Cancerguard are currently marketed as laboratory-developed tests under the Clinical Laboratory Improvement Act, leaving patients to pay about $700 and $900, respectively. Elena Meng of Gabelli Funds estimates widespread coverage could create a $60 billion annual U.S. market by 2030, with a global market of $150 billion. Multi-cancer early detection tests use a single blood draw to identify tumor biomarkers, while AI and machine-learning models assess a cancer fingerprint and its likely tissue of origin. Galleri can detect signals for more than 50 cancer types and identify the likely origin with 93.4% accuracy, but positive results require additional diagnostic testing and negative results do not rule out cancer. Evidence on whether the tests improve outcomes remains contested: a three-year U.K. trial found no significant increase in early detection or reduction in late-stage diagnoses against standard care, while results presented in May showed a 26% reduction in stage IV diagnoses across 12 deadly cancers by the third screening round. Doctors also warn about follow-up costs, anxiety and uncertain effects on cancer mortality.