FDA Schedules Advisory Committee Meeting for Galleri Multi-Cancer Early Detection Test
The FDA has scheduled an advisory committee meeting for September 2026 to review Grail's premarket approval application for the Galleri multi-cancer early detection blood test. Galleri was launched as a laboratory-developed test in 2021 and submitted for FDA approval this year, but a key trial did not meet its primary endpoint. Grail CEO Josh Ofman stated that the company still expects Galleri to receive FDA approval in the first half of 2027.
Brief Overview
- A U.S. Food and Drug Administration (FDA) advisory committee meeting is scheduled for September 2026 to evaluate data on Grail's Galleri multi-cancer early detection blood test.
- Grail launched Galleri as a laboratory-developed test in 2021. The test is designed to detect signals for multiple cancers from a single blood sample, but faced a setback in February when a clinical trial missed its primary endpoint.
- CEO Josh Ofman told analysts on an earnings call this week that Grail still expects Galleri to receive FDA approval in the first half of 2027.
In-Depth Analysis
The FDA's external expert panel will review Grail's premarket approval application for Galleri, which was submitted earlier this year.
Shortly after Grail submitted its application, the company revealed that a three-year landmark trial conducted with the UK's National Health Service (NHS) failed to demonstrate a statistically significant reduction in late-stage cancer diagnoses.
However, Grail stated that the study showed favorable trends toward reductions in stage III and IV cancers across a 12-cancer group.
On the earnings call, Ofman, who became CEO in June, said the combined findings from Grail's studies support the potential of MCED screening to identify early-stage cancers at a population scale.
In the second quarter, Grail sold more than 61,000 Galleri tests, a 35% year-over-year increase in volume, and completed expansion of its sales and medical teams.
Analysts on the call focused their questions on the possibility of the FDA committee meeting. TD Cowen's Dan Brennan said in a research note after the meeting that the experts selected for the advisory committee will be key to watch, as the FDA follows committee decisions about 80% of the time. The analyst sees a 75% likelihood of FDA approval.
Although other companies, including Abbott, have launched or are developing MCED screening products, Galleri, if approved by the FDA, would become the first such test to receive approval.
The FDA designated Galleri, which identifies DNA shed by cancer cells, as a breakthrough device in 2018. In 2023, an FDA advisory committee met to discuss MCED tests and study designs.