Federal health advisers have backed Galleri, an early detection blood test from the health care company Grail that screens for multiple cancers, despite a close vote on whether it has been shown to be effective.
The panel also voted 7-2, with one abstention, that the benefits of Galleri outweigh its risks, but was more divided over how well it performs, voting 6-4 that there was reasonable assurance of effectiveness.
Some committee members questioned whether the evidence showed that detecting cancers with Galleri would translate into better outcomes for patients, while others raised doubts about whether the data supported describing the test as an “early” detection tool.
Stanley Lipkowitz, MD, PhD, of the National Cancer Institute, who voted against the test’s effectiveness and abstained from the vote on its risk-benefit profile, said the FDA needed to be “more critical” before approving it.
“I honestly feel that we didn’t have the data to show effectiveness,” Lipkowitz said during the meeting. “I think we need to set the bar here higher because it’s the first one—it’s a transformative test.”
“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening—helping find more cancers safely, when they may be easier and less costly to treat,” Josh Ofman, MD, MSHS, Grail’s CEO. “We believe the panel’s recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test.”
Grail said it expects the agency to make a final decision on the company’s application in the coming months.
