U.S. — Grail announced in February that a study of its Galleri blood test, conducted in partnership with the National Health Service (NHS) in the U.K., did not achieve its primary objective. The study aimed to demonstrate a reduction in the incidence of Stage 3 and 4 cancers over time.

The Galleri test identifies traces of 50 different cancer types from a single blood sample. It serves as an indicator to medical professionals, suggesting areas for further investigation rather than providing a direct cancer diagnosis. Grail is also conducting a separate study, Pathfinder 2, involving 35,000 patients in North America.

The U.S. Congress passed legislation in February that allows Medicare reimbursement for multi-cancer early detection tests starting in 2028. This legislation also specifies that the Galleri test should not replace existing cancer screening methods. The U.S. Food and Drug Administration has assessed the Galleri test as a breakthrough device for detecting multiple cancer types, along with the Cancerguard test by Exact Sciences.

Megan Hall, vice president of medical affairs for Grail, described the technology as a fundamental change in cancer screening. "It's a real fundamental shift in how we think about cancer screening," Hall said. "Instead of screening for individual cancers, we can now screen an individual for multiple cancers simultaneously."

Common screening tests in the U.S. currently target five cancers: breast, colon, cervical, prostate, and lung. Hall noted that in the third year alone, the test demonstrated a 26% reduction in Stage IV cancers. "The third year alone, we saw a 26% reduction in Stage IV cancers — pancreatic cancer, liver cancer, lung cancer, gastric cancer and a handful of others," Hall said. She also explained that the test's ability to predict the cancer signal origin helps physicians pinpoint where to look to confirm the presence of cancer. "That cancer signal origin prediction is a really important feature of the technology because it directs your physician on where to go to look to confirm the presence or absence of that cancer," Hall said.