Controversial Cancer Test Passes Key FDA Vote Amid Expert Division

Grail's Galleri blood test, which aims to screen for more than 50 types of cancer in their early stages, has moved closer to potential approval by the U.S. Food and Drug Administration (FDA). The test passed a key vote by an FDA advisory committee on Wednesday, despite ongoing debate among experts regarding its effectiveness and the underlying technology.

Known as a liquid biopsy, the Galleri test analyzes blood samples for circulating tumor cells or DNA fragments. While liquid biopsies are established for detecting and monitoring advanced cancers, their application in early detection is considered newer and less tested. The test has been available since at least 2021, though without FDA clearance.

Members of the advisory committee agreed on the test's safety, but the vote on efficacy was not unanimous. Some members expressed reservations after the vote. "Perhaps my 'yes' is a hopeful rather than an accurate one," committee member Victor van Berkel, chief of thoracic surgery at the University of Louisville, told The Washington Post.

Grail CEO Josh Ofman stated that the vote reinforces the strength of Galleri's clinical evidence. However, critics like van Berkel emphasize the need for more proof to demonstrate benefits, particularly for cancers that currently lack screening methods.

Galleri is among several multi-cancer early detection tests in development, distinguishing itself by its broad scope, which includes screening for cancers such as bladder, breast, colorectal, skin, and stomach. The FDA's final decision on the test's approval is anticipated later.