GRAIL Confirms Q2 2021 Introduction of Galleri, First-of-Kind Multi-Cancer Early Detection Blood Test

GRAIL has confirmed that it expects to introduce Galleri™, its multi-cancer early detection blood test, in the second quarter of 2021.

In December 2020, GRAIL completed the enrollment of PATHFINDER, a prospective, 6,600-participant multi-site interventional study conducted under a U.S. Food and Drug Administration Investigational Device Exemption application to evaluate the implementation of Galleri in clinical practice. PATHFINDER has completed its second planned independent Data and Safety Monitoring Board review.

GRAIL expects to present initial results from PATHFINDER, and additional clinical validation from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA), in the first half of 2021. The data from PATHFINDER and CCGA are expected to support Galleri’s introduction as a laboratory developed test.

GRAIL is conducting what it believes to be one of the largest clinical study programs of its kind, with more than 134,000 participants enrolled to date. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers, more than 45 of which lack recommended screening tests today, with a false positive rate of less than 1%. Galleri can also determine the tissue of origin from cancer signals.

Galleri is under investigational use in PATHFINDER, where it is being used to guide clinical care. Galleri is also expected to be offered to eligible patients in the United Kingdom starting in 2021 as part of a partnership with the UK’s National Health Service to support its Long Term Plan for earlier cancer diagnoses in an effort to transform cancer outcomes.

“We are excited by the progress made in our mission to detect cancer and what’s to come with the introduction of Galleri,” said GRAIL CEO Hans Bishop. “We are encouraged by the significant early interest in Galleri from health systems, medical practices, and self-insured employers.”

Read the full press release here.