GRAIL continues to drive progress in clinical evidence generation and commercial use of GalleriⓇ, a first-of-its-kind multi-cancer early detection (MCED) blood test. In clinical studies, Galleri has shown the ability to detect more than 50 types of cancer, many of which have no current screening. We are continuing to see momentum in the commercial space, including our first life insurance carrier partnership to offer Galleri through life insurance carrier John Hancock’s Vitality Program, a new partnership to offer Galleri as an employee benefit through Carrum Health’s oncology offering to self-insured employers, and deployment of Galleri testing at health system leader Henry Ford Health in Michigan. We expanded our clinic sales force in Q3 and are already seeing a meaningful increase in tests ordered.

In September, GRAIL shared final results from PATHFINDER, our first  interventional study of the implementation of Galleri in the clinic setting, at the European Society of Medical Oncology (ESMO) Congress. The study was designed to evaluate the clinical care pathways following a “cancer signal detected” Galleri test result, measure the time required to achieve diagnostic resolution, and assess the implementation and performance of Galleri in a clinical care setting. MCED-predicted cancer signal origin had >97% accuracy, allowing for targeted diagnostic evaluations and time to cancer diagnosis of less than three months for participants with a true positive signal. Importantly, data demonstrated that adding MCED to standard of care screening more than doubled the number of cancers detected, and approximately half of the MCED-detected new cancers were Stage I or II. The positive predictive value, or chance that a positive test resulted in identification of a cancer, was ~40% – which is consistent with findings from the interim analysis and the previous case-controlled Circulating Cell-free Genome Atlas (CCGA) study.

GRAIL also shared an analysis of the first 38,154 commercial Galleri test results. The analysis showed a 1.1% cancer signal detection rate in the commercial setting, consistent with the PATHFINDER results.

Among 326 patients with a positive cancer signal detected result and short-term follow up (as voluntarily reported by the ordering providers), 108 cancers have been confirmed by the ordering providers to-date, representing 28 different cancer types. 59% of identified cancers had no recommended cancer screening test, including, among others, Stage I pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal tumor (GIST) cancers and Stage II rectal, liver, and head and neck cancers.

Other business highlights:

• In September, life insurance carrier John Hancock, the US division of Toronto-based Manulife, announced it is offering access to GRAIL’s Galleri test to a pilot group of existing customers through the John Hancock Vitality Program, in collaboration with reinsurer Munich Re Life US.

• In September, Henry Ford Health, one of the nation’s leading academic medical centers recognized for excellence in clinical care, research and education, was announced among the early group of healthcare providers in the U.S. to offer Galleri. Henry Ford team members and their dependents who are enrolled in a company-sponsored Michigan insurance plan may be eligible for the Galleri test at no cost.
• In October, GRAIL and Carrum Health announced a first-of-its-kind partnership to provide the Galleri test as part of Carrum Health’s oncology offering to self-insured employers. Through the partnership, employers who offer Carrum Health benefits can provide eligible employees access to the Galleri test, and members who receive a signal detected from the Galleri test can work with a Carrum Health Center of Excellence for diagnostic evaluation and guideline-concordant treatment planning. Galleri is being offered as part of Carrum Health’s comprehensive value-based cancer care to improve outcomes and reduce costs.
• In October, as part of the collaboration between GRAIL and the NHS in England, GRAIL and collaborators published a manuscript describing the NHS-Galleri trial design in the journal Cancers. The prospective randomized controlled NHS-Galleri trial is the largest study of an MCED test, having enrolled ~140,000 participants throughout England. The study will evaluate the clinical utility of the Galleri test alongside current standard of care to reduce late-stage cancer diagnoses.