FDA Advisory Panel Backs Approval of Galleri Multicancer Blood Test

A U.S. Food and Drug Administration (FDA) advisory panel backed approval of the multicancer early-detection blood test Galleri, finding that its benefits outweigh its risks.

According to BioPharma Dive on the 24th (local time), the FDA’s Molecular and Clinical Genetics Panel recommended approval of Grail’s Galleri multicancer blood test in a vote of 7 in favor, 2 opposed and 1 abstention.

The panel unanimously agreed that the test was safe, but narrowly supported its effectiveness, with 6 votes in favor and 4 opposed. Grail has submitted a premarket approval (PMA) application for Galleri.

The FDA generally follows the recommendations of its advisory panels. Canaccord Genuity analysts said, “This is a strong predictor of FDA approval.”

Galleri is a test that uses a single blood draw to detect cancers for which no established screening methods exist. It looks for cancer signals by analyzing methylation patterns in cell-free DNA circulating in the blood and, if a signal is found, identifies the tissue or organ associated with it.

Panel members stressed that the test should not replace screening tests for cancers such as breast, cervical, colorectal and lung cancer that are recommended under current medical guidelines.

Deborah Armstrong, a professor of oncology at Johns Hopkins School of Medicine, said, “The biggest concern is that people may be falsely reassured and not get the recommended screening,” adding, “If they are adequately informed, it is acceptable.”

At the meeting, members of the public also spoke about Galleri detecting their cancers early. Kevin McFarland, a retired firefighter from Ohio who was diagnosed with stage 1 esophageal cancer, said, “This test caught the cancer so early and saved my life.”

However, the panel was cautious because data on the test’s reliability for some cancer types are limited. Charity Morgan, a professor of biostatistics at the University of Alabama, noted, “There is not yet evidence that this test can detect those types of cancer.”

Galleri did not meet its primary endpoint in a clinical trial led by the U.K. National Health Service (NHS). Grail emphasized, however, that its data showed a signal for detecting early-stage cancers.

Grail said Galleri detected about 4 to 7 times as many cancers as standard care alone. The company said the test is intended to supplement, not replace, guideline-recommended screening.

Grail has sold Galleri since 2021 as a laboratory-developed test (LDT) that does not require FDA approval.