The FDA has approved SimpleScreen CRC, a blood-based colorectal cancer screening test developed by Brisbane, Calif.-based Freenome, on July 27, according to a July 27 news release.
This is the second blood test cleared for average-risk CRC screening and the first to be commercialized through Abbott.
Abbott will exclusively commercialize the test in the U.S. beginning this fall, adding it alongside Cologuard in its existing CRC screening portfolio. Under the commercial agreement signed in August 2025, Freenome will receive a $100 million milestone payment from Abbott tied to the FDA approval.
SimpleScreen CRC detects signals associated with colorectal cancer from cell-free DNA in the blood and is indicated for adults 45 and older at average risk who are referred by a healthcare provider for screening. A positive result must be followed by a colonoscopy.
The test was evaluated in the PREEMPT CRC study, which enrolled more than 48,000 asymptomatic average-risk adults across more than 200 sites. It detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity, with 90.4% specificity for advanced colorectal neoplasia.
With FDA approval, SimpleScreen CRC meets Medicare coverage criteria for blood-based CRC screening tests.
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