Grail announced today that it expects to introduce its Galleri multi-cancer early detection blood test in the second quarter of 2021.
Menlo Park, Calif.-based Grail completed enrollment for the Pathfinder prospective study of Galleri in clinical practice just last month, according to a news release.
The 6,600-participant, multi-site, international study under an FDA investigational device exemption application has already completed its second planned independent data and safety monitoring board review and will have initial results, plus additional clinical validation data from a separate study, available in the first half of this year.
In combining the results from the Pathfinder trial with the foundational circulating cell-free genome atlas study, Grail expects the data to support Galleri’s introduction as a laboratory-developed test.
An earlier version of Galleri previously demonstrated the ability to detect more than 50 types of cancers (among which, 45 lack recommended screening tests today, the company said) with a low false-positive rate of less than 1%.
Grail also expects to be able to offer Galleri to eligible patients in the United Kingdom starting this year as part of a partnership with the UK National Health Service.
“Cancer remains the second-leading cause of death in large part because we lack recommended screening tests for the majority of deadly cancers. We are excited by the progress made in our mission to detect cancer earlier and what’s to come with the introduction of Galleri this year,” Grail CEO Hans Bishop said in the release. “We are encouraged by the significant early interest in Galleri from health systems, medical practices, and self-insured employers.”