An FDA advisory panel voted to back Grail’s Galleri blood test for signals linked to 50-plus cancers, potentially paving the way for Medicare and private-insurance coverage. The test is meant to supplement standard screening, and false positives and negatives are possible.
The panel voted 7-2, with one abstention, that potential benefits outweighed risks; it unanimously supported the test’s safety and split 6-4 on its effectiveness. Galleri is already sold in the U.S. out of pocket, typically for $700 or more. The report says FDA approval could open the door to Medicare and private insurers covering at least part of the cost.
A study of 140,000 older adults found Galleri detected about one-third of cancers diagnosed over a year, the Associated Press reported. Grail says around six in 10 people whose test showed a cancer signal were diagnosed after further testing. The report also says the test is less accurate for early-stage cancers; a negative result does not rule out cancer.
