Freenome vs GRAIL

An internist whose average-risk patient is 47 can look to an FDA-approved blood screen. Freenome's SimpleScreen CRC received PMA P250029 on July 24, 2026 for adults 45 and older, with colonoscopy after a positive result, and Abbott is to commercialize it. For that patient GRAIL's Galleri loses: galleri.com says the test has not been cleared or approved by the FDA, and GRAIL's release describes adults 50 and older.

GRAIL fits an internist or health system weighing multi-cancer screening for patients 50 and older. GRAIL says Galleri looks for signals from more than 50 cancer types, and it is sold as a CLIA-lab test, Rx only. The PMA, submitted in full on January 29, 2026, is under FDA review. The advisory panel voted 7 yes, 2 no and 1 abstention on September 23, 2026 that benefits outweigh risks, with effectiveness at 6 yes and 4 no. Per Diagnosis (Berl) and BMJ coverage, the randomized NHS-Galleri trial missed its primary endpoint.

Freenome's homepage and approval release give no price.