September 2026—The FDA has approved Freenome’s SimpleScreen CRC, a blood-based screening test for colorectal cancer in adults 45 and older who are at average risk for developing the disease. The test detects signals associated with colorectal cancer from cell-free DNA in the blood.
SimpleScreen CRC was evaluated in PREEMPT CRC, a prospective, multicenter, cross-sectional observational study that enrolled more than 48,000 asymptomatic adults aged 45 to 85 years at average risk of colorectal cancer and who were willing to undergo a standard-of-care screening colonoscopy. In a prespecified analysis adjusted to match the U.S. census, the test detected colorectal cancer with 81.1 percent sensitivity and advanced precancerous lesions with 13.7 percent sensitivity, including 30.7 percent for advanced precancerous lesions with high-grade dysplasia. The test showed 90.4 percent specificity for advanced colorectal neoplasia.
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare. Abbott will exclusively commercialize the test in the United States this fall.
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