A Food and Drug Administration advisory panel on Wednesday endorsed Galleri, a blood test designed by the biotech firm Grail to screen for multiple types of cancer, concluding that the benefits of the test outweighed its risks.
The panel voted 10 to 0 that it believed there is “reasonable assurance” the test is safe.The panel voted 6 to 4 that there was reasonable assurance the test is effective. And it voted 7 to 2 with one abstention that it believed “the benefits of Galleri outweigh the risk for use in patients who meet the criteria specified in the proposed indication.”
The FDA is not obliged to follow the advice of these panels, but it often does.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
Individual plans
Group plans
View All Plans
To read the rest of this story subscribe to STAT+.
Subscribe
