US FDA advisers endorse Grail cancer test's benefits in key vote

Galleri screens for multiple cancers from a single blood draw. In a US study, it detected 35% of cancers within 12 months and achieved a specificity of 99.85%.

Results from a separate study in Britain were broadly consistent, reinforcing the test's low false-positive rate and cancer-detection capabilities.

The committee also emphasized that doctors must clearly explain test limitations to patients so they do not skip proven screenings such as mammograms and colonoscopies, urging that Galleri must be an "addition, not substitution" to standard care.

Both Grail's Galleri and Abbott's ABT.N Cancerguard are available to patients under Clinical Laboratory Improvement Amendments regulations, but neither of them is FDA-approved.

A panel of outside experts advising the US FDA said on Wednesday the benefits of Grail's GRAL.O blood-based cancer detection test outweigh its risks, paving the way for a potential landmark approval in cancer screening.

In a 7-2 vote with one abstention, the expert panel concluded that the test Galleri's ability to catch difficult-to-detect cancers justified its use in adults aged 50 and older.

While the committee unanimously endorsed the test's safety, members split 6-4 on whether the evidence demonstrated its effectiveness.

"This increases our confidence even more on FDA approval — almost derisked," Subbu Nambi, analyst at Guggenheim, said. "There is some debate about label, but we ultimately think FDA will approve for a wide range of cancers."

The US Food and Drug Administration is not bound by its panel's votes but weighs them heavily when making final decisions. A final decision on whether Galleri can be sold nationwide is expected in the coming months.