The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted Sept. 23 in favor of approving Grail’s Galleri multi-cancer early-detection blood test. The vote marks the first time a test of this kind has reached this stage.
The panel voted 7-2, with one abstention, that the test’s benefits outweigh its risks and 6-4 that the test is effective. Panel members unanimously agreed that the test is safe.
Here’s what to know:
- Panel recommendations are not binding, and the FDA has not said when it will make a final decision.
- Galleri is a prescription-only test for adults 50 and older. It analyzes blood for cancer DNA fragments and predicts where in the body a cancer may have started.
- The test is currently available by prescription for $949, though Congress has approved Medicare coverage for multi-cancer detection tests that receive FDA approval, according to a Sept. 23 report from NPR.
- Some panelists said the test’s effect on cancer deaths remains unproven.
Most panelists agreed Galleri should not be marketed as an “early” detection test and that product labeling should direct patients to continue routine screenings such as mammograms and colonoscopies. - The panel reviewed a Grail-funded study published Sept. 22 in Nature Medicine. The study analyzed data from 35,878 adults 50 and older. About 60% of participants who had a cancer signal detected were eventually diagnosed with cancer. Nearly three-quarters of the cancers the test found were types that have no recommended screening.
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