03:53 AM EDT, 07/15/2024 (MT Newswires) -- Grail Inc. ( GRAL ) said Monday it has completed the enrollment of more than 35,000 people for its US study of Galleri, the company's potential multi-cancer early detection test, at more than 30 health care facilities.
The company also said it has completed the third and final round of study visits for a UK National Health Service-backed Galleri trial, which enrolled more than 140,000 participants.
According to Grail Chief Executive Bob Ragusa, the studies will "significantly expand our existing clinical validation and performance evidence for the Galleri test." He added that the testing will support the premarket approval application for the diagnostic tool submitted with the US Food and Drug Administration where it is currently being evaluated for a Breakthrough Device Designation.
The company expects results from the first 25,000 participants in the US study in H2 2025, while final results for the NHS-backed study are anticipated in 2026.
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