An FDA panel recommended Grail’s Galleri test for adults 50 and older: it voted 7-2, with one abstention, that the test’s benefits outweigh its risks. Members backed safety but split 6-4 on effectiveness. Grail expects an FDA decision in the next few months.
Galleri screens for multiple cancers from one blood draw, detecting cancer-specific methylation patterns in cell-free DNA; when it finds a signal, it is designed to predict its likely origin, Grail says. The company says the test is meant to supplement, not replace, established screenings such as mammograms and colonoscopies. Panel members unanimously supported its safety, and FDA advisory recommendations are not binding.
The committee reviewed two Grail-sponsored trials, one involving more than 140,000 UK National Health Service participants and another with more than 35,000 North American patients. Neither met its primary endpoints of reducing overall mortality or late-stage cancer diagnoses. A later NHS-study update showed fewer Stage IV diagnoses over three years; a US study cited by Reuters reported 99.85% specificity and identified 35% of cancers over 12 months. Galleri costs $949 out of pocket. Under the FDA-CMS RAPID pathway, Medicare reimbursement could begin roughly two months after market authorization if the test is approved.
