The FDA has approved Freenome's SimpleScreen CRC, a blood-based screening test for average-risk adults aged 45 and older, allowing Abbott to launch it in the U.S. this fall. In a large trial of more than 48,000 adults, the test showed 81.1% sensitivity for colorectal cancer but lower detection rates for advanced precancerous lesions. The clearance meets Medicare coverage criteria, triggers a $100 million milestone payment from Abbott, and positions Freenome to pursue additional blood-based cancer screens.
FDA Clears Freenome's SimpleScreen CRC Blood Test for Colorectal Cancer; Abbott to Launch in U.S.
FILE PHOTO: A U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025. REUTERS/Dado Ruvic/Illustration/File Photo
The U.S. Food and Drug Administration has approved Freenome's blood-based colorectal cancer screening test, SimpleScreen CRC, for average-risk adults aged 45 and older. The clearance paves the way for partner Abbott to exclusively commercialize the test in the United States this fall, the companies said.
Clinical Performance and Study
SimpleScreen CRC analyzes DNA fragments circulating in the blood to identify signals associated with colorectal cancer. The test was evaluated in a large clinical study that enrolled more than 48,000 adults across more than 200 sites. In a prespecified analysis, the assay detected colorectal cancer with 81.1% sensitivity. It detected advanced precancerous lesions with 13.7% sensitivity overall and 30.7% sensitivity for high-risk precancerous growths.
Commercial and Coverage Implications
With FDA clearance, SimpleScreen CRC meets Medicare coverage criteria and aligns with updated American Cancer Society guidelines that include blood-based colorectal cancer screening as an option. Under a 2025 commercialization agreement, Abbott will pay Freenome a $100 million milestone tied to the approval and will be Freenome's exclusive U.S. commercialization partner.
Market Context and Company Plans
Freenome's shares rose about 10% in premarket trading after the announcement. The new offering will compete with Guardant Health's FDA-approved Shield blood test in the emerging market for noninvasive cancer screening. Freenome said it plans to expand its platform to develop additional blood-based cancer screening tests, including candidates targeting lung cancer.
Background
Colorectal cancer, which affects the colon or rectum, is the third-most common cancer diagnosed in the United States, according to the American Cancer Society.
Reporting by Sahil Pandey in Bengaluru; Editing by Sahal Muhammed.
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