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A single blood draw that screens for more than 50 cancers substantially increased cancer detection when added to standard screening, identifying cancers that otherwise might have gone undetected until later stages, according to a new study from the Oregon Health & Science University Knight Cancer Institute.

The results from the PATHFINDER 2 study, published in Nature Medicine, show the efficacy of GRAIL's Galleri test, which uses a machine-learning algorithm to examine chemical patterns that distinguish cell-free DNA originating from healthy cells versus cancerous cells.

The findings arrive at a pivotal moment for the field of multi-cancer early detection. On Wednesday, Nima Nabavizadeh, M.D., lead author of the study and professor of radiation medicine and director of early detection clinical research at the OHSU Knight Cancer Institute, is scheduled to present the results before a Food and Drug Administration advisory committee reviewing evidence supporting potential approval of the Galleri test.

"We screen for just five cancers, yet the ones we can't screen for cause up to 70% of cancer deaths in this country; that's the gap this blood test helps close," Nabavizadeh said. "It finds many of these cancers while they're still asymptomatic and localized, when cure is still possible. It's not a replacement for standard screening, but a powerful complement to it."

The PATHFINDER 2 trial—the study supporting GRAIL's application for FDA approval of the Galleri test—enrolled 35,878 adults 50 and older across the United States and Canada, making it the largest interventional multi-cancer early detection study conducted in North America.

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