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FDA panel endorses first-of-a-kind cancer blood test from Grail
The panel voted 7-2 to recommend the first multi-cancer blood test, saying it may help find cancers earlier despite unresolved accuracy questions.
- On Wednesday, a Federal advisory panel to The FDA recommended the agency approve Grail's Galleri blood test, marking the first federal advisory group to back an experimental multi-cancer detection test for people 50 and older.
- Grail's DNA-based Galleri test uses a single blood draw to identify signals from up to 50 cancer types, positioned as additive to standardized screenings like mammograms and colonoscopies rather than a replacement.
- The advisory committee reviewed major clinical studies involving more than 140,000 patients in the National Health System and over 35,000 North American patients, though experts noted the test often failed to detect early-stage cancers in these trials.
- Ultimate approval by The FDA could facilitate widespread adoption and insurance reimbursement for the test, which currently costs $949; a final decision is expected in a few months, though the agency is not bound by the panel's advice.
- Notably Phil Castle, director of the National Cancer Institute's Division of Cancer Prevention, warned that "Routine approval and broad population rollout would risk harm and waste resources," while Michelle Tarver of The FDA emphasized technologies with such reach demand careful evaluation.
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US FDA advisers endorse Grail cancer test's benefits in key vote
A panel of outside experts advising the US FDA said on Wednesday the benefits of Grail's blood-based cancer detection test outweigh its risks, paving the way for a potential landmark approval in cancer screening.
·London, United Kingdom
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Total News Sources13
Leaning Left3Leaning Right0Center6Last UpdatedBias Distribution67% Center
Bias Distribution
- 67% of the sources are Center
67% Center
L 33%
C 67%
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