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FDA panel backs Grail’s Galleri blood test for premarket approval
The FDA panel voted in favor of recommending Grail’s multi-cancer early detection test for premarket approval, which uses biomarkers like circulating tumor DNA in blood or urine.
Efforts to detect multiple cancers from a single blood draw are gaining momentum after a US Food and Drug Administration panel backed Grail’s “Galleri” multi-cancer early detection blood test for premarket approval, according to SCMP Economy.
MCED tests are designed to identify signals of cancer in healthy, asymptomatic people by analyzing abnormal molecules in bodily fluids, including circulating tumor DNA (ctDNA), in samples such as blood and urine.
While the US endorsement marks a landmark step for the emerging MCED field, SCMP Economy notes that experts in Hong Kong remain cautious about the clinical value and that broader adoption there could face challenges.