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FDA Panel Backs Grail’s Multi-Cancer Blood Test

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Federal health advisers on Wednesday endorsed Grail Inc.’s Galleri blood test, which looks for signals of multiple cancers in healthy people with a single blood draw, voting 7-2 with one abstention that the DNA-based test offers more potential benefits than risks. The panel emphasized the test does not diagnose cancer and requires follow-up care for positive results, warning it is far from clear how well the technology works for early detection. Experts noted the test missed about two-thirds of cancers in Grail’s study of 140,000 older adults and called for more research, with one panel member describing their support as “hopeful rather than accurate.” The FDA is not bound by the advice but a favorable decision could enable wider U.S. adoption and insurance coverage, including Medicare.

Currently, the Galleri test costs $700 or more out-of-pocket, and experts stressed it should supplement, not replace, existing screenings like mammograms and colonoscopies. Grail’s test can detect signs of over 50 cancers, including those without standard screening options such as liver and ovarian cancer, but lacked data showing reduced cancer deaths. The final FDA decision is expected in a few months.