FDA Panel Recommends Grail's Multi-Cancer Early Detection Galleri Test
An FDA panel voted in favour of US company Grail's Galleri test, recommending it for premarket approval in a landmark decision for MCED blood tests.
Quick Look
A US FDA panel voted in favour of US company Grail’s Galleri test on Thursday, recommending premarket approval in a landmark decision for multi-cancer early detection blood tests.
AI-generated summary
Why It Matters
Multi-cancer early detection (MCED) tests analyse abnormal molecules in bodily fluids to identify signs of cancer in asymptomatic individuals.
In a landmark decision for the emerging field of multi-cancer early detection (MCED) blood tests, a US Food and Drug Administration (FDA) panel on Thursday voted in favour of US company Grail’s “Galleri test”, recommending it for premarket approval.
MCED tests seek to identify signs of cancer in healthy, asymptomatic individuals by analysing abnormal molecules, including circulating tumour DNA (ctDNA), in bodily fluids such as blood and urine.
What to Watch
AI outlook — possibilities, not facts
FDA issues final premarket approval decision
Likely · Within months
Open Questions
- When will the final FDA approval decision be made?
- How will insurance coverage apply to the Galleri test?
