FDA clears Freenome's blood test for colorectal cancer screening

• The test detected colorectal cancer with 81.1% sensitivity and high-risk precancerous growths with 30.7% sensitivity in a study of over 48,000 adults across 200+ sites
• Abbott will exclusively commercialize the test under a 2025 deal that includes a $100 million payment to Freenome tied to FDA approval
• Colorectal cancer is the third most commonly diagnosed cancer in the U.S., and the test meets Medicare coverage criteria while already being included in American Cancer Society screening guidelines

FDA Approves Freenome's Blood Test for Colorectal Cancer Screening

The U.S. FDA has approved Freenome's blood-based colorectal cancer screening test, SimpleScreen CRC, for average-risk adults aged 45 and older. Partner Abbott will exclusively commercialize the test in the U.S. starting this fall, marking Freenome's first commercial product.

Key Performance Data:

The test was validated through a large-scale study involving over 48,000 adults across more than 200 sites. Results showed 81.1% sensitivity in detecting colorectal cancer in prespecified analysis. For precancerous growths, sensitivity was 13.7% overall, rising to 30.7% for high-risk precancerous growths.

Financial Terms:

Under the commercialization agreement signed in 2025, Freenome will receive a $100 million milestone payment from Abbott tied to the FDA approval.

Market Implications:

The test will compete with Guardant Health's existing colorectal cancer screening product in the U.S. market. The approval qualifies SimpleScreen CRC for Medicare coverage, and blood-based colorectal cancer screening is already included in updated American Cancer Society guidelines, positioning the product favorably for market adoption.

Technology Platform:

SimpleScreen CRC detects cancer signals from DNA fragments circulating in the blood. Freenome plans to leverage this same technology platform to develop additional blood-based screening tests, including for lung cancer.

Market Context:

Colorectal cancer, affecting the colon or rectum, is among the most commonly diagnosed cancers in the U.S., according to the American Cancer Society, highlighting significant market potential for screening solutions.

The approval represents a major advancement in non-invasive cancer screening options for the aging U.S. population.