GRAIL has integrated its Galleri multi-cancer early detection test into the Epic electronic health record platform, allowing clinicians to order the test directly within Epic's workflow, according to a company press release.
The integration gives GRAIL access to Epic's installed base of more than 305 million patient records across U.S. health systems. Epic holds approximately 36% of the U.S. acute care EHR market, making it the largest electronic health record platform in the country.
Galleri uses a blood draw to screen for a signal shared across more than 50 cancer types. The test is available as a laboratory-developed test but lacks FDA approval and Medicare coverage. Without EHR integration, ordering has required clinicians to navigate separate portals, a workflow barrier that has limited adoption primarily to oncology specialists and concierge medicine practices rather than high-volume primary care settings where population-level cancer screening occurs.
The announcement follows GRAIL's recent disclosure that its NHS-Galleri trial in the United Kingdom missed its primary endpoint, raising questions about the test's sensitivity in a real-world screening population. GRAIL has not disclosed updated U.S. commercial volumes or revenue tied to Galleri.
EHR integration has become standard among molecular diagnostics companies. Guardant Health and Exact Sciences have pursued similar Epic integrations for their respective oncology products. The difference for GRAIL is scale: Galleri targets a screening population that extends beyond single-cancer companion diagnostics, but only if ordering reaches primary care physicians who manage the majority of U.S. cancer screening.
The partnership does not address reimbursement. Without payer agreements or health-system-level contracts that reduce out-of-pocket costs, ordering volume may remain constrained even with frictionless Epic integration. GRAIL has not announced pricing changes or coverage agreements tied to the Epic partnership.