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.
48 Articles
48 Articles
FDA Panel Backs Blood Test Designed to Detect More Than 50 Cancers
A simple blood test that could help detect more than 50 types of cancer is moving closer to federal approval, offering new hope for patients who may benefit from earlier treatment. Known as Galleri, the test uses artificial intelligence to analyze DNA fragments in the bloodstream and look for signs of cancer, while also suggesting where the disease may have originated. While supporters see the technology as a potential breakthrough in cancer scr…
FDA Panel votes in favor of a $949 Cancer detecting blood test, but is Galleri ready for approval?
Cancer cells can leave tiny fragments of DNA in the bloodstream. According to USA Today, Galleri studies chemical patterns found on these fragments. A machine-learning system then analyzes the results for signals that could point to cancer.
Panellists expressed reservations about the tests supporting the Grail Galleri test, designed to detect cancer in its early stages
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