- In July 2025, the U.S. National Cancer Institute (NCI) launched the Vanguard Study, enrolling 24,000 adults aged 45–70 to test the effectiveness of multi-cancer early detection (MCED) blood tests by GRAIL and ClearNote Health. The study aims to compare the ability of these tests to detect multiple cancers against standard screening. This large-scale initiative represents a pivotal step toward regulatory approval and widespread clinical use of MCED tests
- In June 2025, GRAIL Inc. announced positive top-line results from its pivotal PATHFINDER 2 study of the Galleri test, covering 25,578 participants. The trial demonstrated strong performance with a positive predictive value (PPV) of 43%, specificity of 99.5%, and a cancer signal origin prediction accuracy of 91%. These findings provide critical clinical validation for Galleri as an effective MCED solution
- In May 2025, Guardant Health received FDA Breakthrough Device Designation for its Shield MCED test, which uses a proprietary methylation-based approach to detect early-stage cancers through a single blood draw. In clinical studies, the test demonstrated a specificity of 98.6% and sensitivity of 75% across several cancer types, enabling faster regulatory pathways for broader access
- In April 2025, GRAIL and athenahealth announced a partnership to integrate Galleri test ordering directly into athenaOne, a leading cloud-based EHR platform. This integration simplifies clinician workflows by enabling over 160,000 providers to order MCED tests seamlessly from their existing systems, accelerating clinical adoption
