U.S. — Grail released research in late May at the American Society of Clinical Oncology meeting regarding two studies. The company reported a 26% reduction in Stage IV cancers with its Galleri test. Grail also announced in February that a separate study in the U.K. through the National Health Service did not meet a primary goal of seeing a reduction in the incidence of Stage 3 and 4 cancers over time.

Congress voted in February to allow Medicare to reimburse the cost of multicancer detection tests starting in 2028. The Galleri test can detect traces of up to 50 different kinds of cancer in a single vial of blood, and the Food and Drug Administration has been evaluating it as a breakthrough device.

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

Grail is conducting a study of more than 142,000 patients in the U.K. through the National Health Service. It is also conducting a study called Pathfinder 2 involving 35,000 patients in North America. The Galleri test does not diagnose cancer but indicates to doctors where to look more closely. Current common screening in the U.S. covers five cancers: breast, colon, cervical, prostate, and lung.

Jonathan Goldman, a lung-cancer specialist at UCLA, said, "Blood-based testing has become central to the way that we think about lung cancer and other cancers because the systems have become so sensitive." He added, "It's possible that at some point our blood testing could become so sensitive that you could find that very small number of cells that would be at risk for causing cancer occurrence years later — but we're not there yet." Grail sets the retail price for the Galleri test at $950. Full FDA approval is required for the tests to be covered by Medicare and other insurance. Galleri and Cancerguard are currently available in the U.S. under a special FDA designation.