FDA panel backs Galleri multi-cancer blood test in 6-4 vote

September 24, 2026 at 04:08 AM2 min

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An FDA advisory panel voted Wednesday to recommend the Galleri multi-cancer blood test, with six members supporting its effectiveness and seven backing its benefit-risk profile. The unanimous safety vote clears a key regulatory hurdle for Grail Inc., though panelists split on whether the test's benefits outweigh its risks. The test is designed for adults 50 and older and detected cancer in 287 of more than 35,000 study participants.

Key Facts

The FDA advisory panel voted 6-4 that Galleri's benefits outweigh its risks, with one abstention.
The panel voted 7-2 that the test is effective, with one abstention.
In a study of more than 35,000 participants, Galleri detected cancer signals in 287 people, about 60% of whom were later diagnosed with cancer.
Galleri accurately predicted the cancer's origin site in about 91% of cases.
No multi-cancer early detection test has been approved by the FDA, according to the American Cancer Society.

Panel Vote

The FDA advisory panel voted unanimously that Grail Inc. demonstrated the Galleri test is safe. On effectiveness, six panelists voted in favor and four against, with one abstention. On whether benefits outweigh risks, seven voted in favor and two against, with one abstention. Ajay Goel, professor at City of Hope, called the vote "an important step forward for the field."

Clinical Evidence

A study published Tuesday in Nature Medicine included more than 35,000 participants. Galleri detected cancer signals in 287 people, about 60% of whom were later diagnosed with the disease. The test accurately predicted the cancer's origin site in about 91% of cases. Grail emphasized in its FDA application that a negative result does not definitively rule out cancer.

Regulatory Context

No multi-cancer early detection test has been approved by the FDA, according to the American Cancer Society. Galleri is currently designed for people aged 50 and over. Goel said the real goal is to find cancers early enough to change patient outcomes, but longer-term evidence is still needed.