FDA clears Freenome's SimpleScreen CRC blood test, Abbott to market it in U.S.

The U.S. Food and Drug Administration has given clearance to Freenome’s SimpleScreen CRC, a blood-based test for colorectal cancer. Abbott will be the exclusive U.S. marketer and will pay Freenome $100 million under a 2025 commercialization agreement.

The test is intended for adults aged 45 and older who are at average risk, offering an alternative for those who avoid colonoscopy or stool-based screening.

Colorectal cancer remains one of the most common cancers and the second leading cause of cancer death in the United States, with rising incidence among people under 50. Current screening relies on colonoscopy, CT colonography, sigmoidoscopy, and the at-home fecal immunochemical test (FIT).

While blood tests have not been the preferred screening tool because of lower sensitivity, Freenome’s assay aims to improve uptake among patients reluctant to undergo existing methods.