Dive Brief:
- A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
- Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit 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 continues to expect Galleri to receive FDA approval in the first part of 2027.
Dive Insight:
The FDA’s panel of outside experts will review Grail’s premarket approval application for Galleri, submitted earlier this year.
Shortly after Grail filed the submission, the company revealed its landmark three-year trial with the U.K.’s National Health Service failed to demonstrate statistically significant reduction of late-stage cancer diagnoses.
However, Grail said the study showed a favorable trend toward fewer Stage III and IV cancers in a group of 12 cancers.
On the earnings call, Ofman, who became CEO in June, said the combined findings of Grail’s research support the potential of MCED screening at population scale to identify cancers at earlier stages.
In the second quarter, Grail sold more than 61,000 Galleri tests, a 35% increase in volume year over year, and completed an expansion of its sales and medical teams.
Analysts on the call focused questions on the potential for an FDA committee meeting. TD Cowen’s Dan Brennan, in a research note afterward, said the experts selected for the advisory panel will be key to watch because the FDA sides with committee decisions around 80% of the time. The analyst views FDA approval as 75% likely.
While other companies, including Abbott, have launched MCED screenings or are developing them, Galleri would become the first such test with FDA approval if it wins the agency’s nod.
The FDA designated Galleri, which identifies DNA shed by cancer cells, as a breakthrough device in 2018. An FDA advisory committee met to discuss MCED test and study designs in 2023.
