Dive Brief:
- Grail has filed for Food and Drug Administration approval of its multi-cancer early detection test, the company said Thursday.
- The premarket approval filing for Grail’s Galleri test focuses on a U.S. study of more than 25,000 people and a randomized, controlled trial the company is running in the United Kingdom.
- Grail President Josh Ofman said at an event in January that approval will be a “major trigger” for evidence-based decisions with U.S. payers and could enable Medicare coverage.
Dive Insight:
Grail began selling Galleri as a laboratory developed test in 2021. At the time, Grail was the subject of an $8 billion buyout bid from parent company Illumina. The companies closed the deal despite lacking the required regulatory clearances, only for Illumina to spin Grail off three years later after failing to win over authorities.
Amid the upheaval, Grail continued to run studies to assess the ability of its Galleri blood test to detect a range of cancers early. The work has resulted in the company having one-year data from 25,490 people in the U.S.-based PATHFINDER 2 study and a U.K. trial that recruited more than 140,000 asymptomatic participants.
Grail has submitted data from the trials to the FDA. The filing also includes a bridging analysis comparing the version of Galleri submitted for FDA approval with the version of the test used in the U.S. and U.K. trials.
The company has filed for approval ahead of further readouts from the trials. At the J.P. Morgan Healthcare Conference in January, Ofman said Grail plans to publish full data from the U.K. trial and the complete, 35,000-participant analysis of the U.S. study around the middle of this year.
Grail reported preliminary U.S. Galleri revenue of $136 million to $137 million last year. The company forecast 22% to 32% growth for 2026. The growth will add to the more than 475,000 commercial Galleri tests that Grail had sold as of January.
Other companies are targeting the market. Exact Sciences, which Abbott is buying for $21 billion, launched a rival multi-cancer early detection kit as a laboratory developed blood test in September. Physicians who order Guardant Health’s Shield test for colorectal cancer screening can opt in to receive results for multiple tumor types.
