Grail Rallies as FDA Staff Flags No Major Concerns for Multi-Cancer Test
The panel will weigh mixed trial results, including 14% fewer stage IV diagnoses and no proven reduction in cancer deaths.
- On Monday, GRAIL shares surged 35% after FDA staff reviewers raised no major concerns about the accuracy of the Galleri blood test designed to detect more than 50 cancers, ahead of Wednesday's advisory panel vote on premarket approval.
- Currently sold by prescription without FDA approval, Galleri is designed to detect more than 50 cancers and complements rather than replaces standard screenings like mammograms or colonoscopies, according to GRAIL.
- Data from the NHS-Galleri trial indicates a 52% positive predictive value, meaning roughly half of positive results are ultimately confirmed as cancer, though the trial missed its primary goal of significantly reducing late-stage diagnoses.
- While the advisory panel's Wednesday vote provides advice rather than a final decision, FDA approval would facilitate insurance coverage; Congress voted to allow Medicare reimbursement for such tests starting in 2028 after full agency review.
- Piper Sandler analyst David Westenberg called the FDA's document release "constructive for Grail," though the agency asked advisers to discuss whether current evidence supports Galleri's characterization as an "early detection" test.
12 Articles
12 Articles
GRAIL Shares Surge 35% After FDA Briefing Raises No Major Concerns
GRAIL’s Galleri multi-cancer early detection test is the focus of an FDA advisory committee review, with briefing documents signaling favorable safety and analytical performance—sparking a roughly 34% surge in Grail shares as investors push expectations ahead of the vote. The company highlights clinical benefits and near-term commercial expansion, including a Samsung financing deal and rising test volumes, even as it continues to post losses. · …
Grail rallies as FDA staff flags no major concerns for multi-cancer test
By Christy Santhosh and Padmanabhan Ananthan Sept 21 (Reuters) - The US FDA's staff reviewers did not raise major concerns about the accuracy and safety of Grail's blood test designed to detect more than 50 cancers, sending the company's shares soari...
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