FDA Panel Narrowly Backs GRAIL’s Galleri Test

An FDA advisory panel gave GRAIL's Galleri multi-cancer blood test a real, but qualified, endorsement on 23 September 2026 — voting narrowly that the test works and more broadly that its benefits outweigh its risks, while stopping well short of unanimous support. The vote is the first time any advisory committee has reviewed a multi-cancer early detection test, and it puts the question squarely in FDA's hands: the agency is not bound by what its own panel just told it.

A landmark review, and a divided one

Multi-cancer early detection (MCED) tests promise something no single-cancer screening test can: one blood draw that looks for a signal common to dozens of cancer types at once, in people who have no symptoms and no reason yet to suspect they are sick. Galleri, developed by GRAIL and already sold in the US as a laboratory-developed test outside FDA's premarket process, is the first MCED test to go before an FDA advisory committee at all — which is why the vote drew unusually close attention even before the panel spoke, and why the closeness of what it said next mattered.

The panel's three votes moved in different directions. On safety, the vote was unanimous: 10 members agreed there is reasonable assurance Galleri does not itself harm the people who take it, a conclusion built in part on data GRAIL presented from more than 165,000 study participants showing no device-related serious adverse events, with most adverse events tied to the blood draw itself rather than the test. On effectiveness — whether Galleri's evidence shows it actually does what it claims — the panel split 6-4. And on the composite question of whether the benefits outweigh the risks overall, it moved back toward support: 7 in favor, 2 opposed, 1 abstention.

What the dissenting votes were about

The panel's public discussion, reported by multiple outlets that covered the meeting, centered on the two-sided risk of a screening test with imperfect precision. A false positive can send an otherwise healthy person toward expensive imaging or an invasive biopsy they did not need, along with the anxiety that comes with it. A false negative carries the opposite risk: a person is told a cancer signal was not detected and may, in response, deprioritize the standard screening — mammography, colonoscopy, low-dose CT — that Galleri is explicitly meant to supplement rather than replace. One panelist who voted against the effectiveness question, cardiothoracic surgeon Victor van Berkel, said his central concern was “false reassurance leading to either ignoring symptoms or other screening guidelines.” Another panelist who ultimately voted yes on benefit-risk described the vote as “a hopeful one rather than an accurate one,” adding that the evidence would likely prove out over time, particularly for cancer types that lack any existing screening test today.

What comes next

An advisory committee vote is a recommendation, not a decision. FDA has final authority over the PMA and has, in other reviews, gone against a panel's majority position. What the 23 September vote does establish is a public record: the agency's own outside experts saw real evidence in favor of Galleri and real, unresolved questions about how well it performs and how it should be labeled and marketed if cleared. FDA has not set a decision date beyond describing one as coming within months. For sponsors developing their own MCED or liquid-biopsy screening candidates, the vote — the first CDRH has taken on this category — is now the closest thing to a template for what an advisory committee will ask, and where it is most likely to push back.

Frequently asked questions

What did the FDA panel vote on 23 September 2026?

FDA's Molecular and Clinical Genetics Devices Panel voted 10-0 that Galleri is safe, 6-4 that there is reasonable assurance it is effective, and 7-2 with one abstention that its benefits outweigh its risks.

How does Galleri work?

It detects a shared cancer signal from cell-free DNA methylation patterns common across more than 50 cancer types from a single blood draw, and predicts the likely tissue of origin. It is intended to supplement, not replace, standard cancer screening in adults 50 and older.

Does the panel vote mean Galleri is approved?

No. FDA is not bound by advisory committee votes and makes the final PMA decision itself. GRAIL submitted the PMA on 29 January 2026; FDA has said a decision is expected in the coming months.

What concerned the panelists who voted no?

The risk that a false positive leads to unnecessary imaging or biopsies, and that a false negative gives false reassurance that causes patients to skip other recommended screening.