The FDA has approved SimpleScreen CRC, a blood-based screening test developed by Freenome, for average-risk adults aged 45 and older. The test detects cell-free DNA linked to colorectal cancer, and Abbott plans to make it commercially available this fall.
The approval is based on results from the PREEMPT CRC study. The test detected 81.1% of colorectal cancer cases overall and identified 100% of cases in adults aged 45 to 49. It also detected 13.7% of advanced precancerous lesions, with a higher detection rate of 30.7% for lesions with high-grade dysplasia. The test showed a specificity of 90.4%, meaning it correctly identified most people without advanced colorectal disease.
Researchers are also developing a next-generation version of the test. Early results presented at the 2026 ASCO Gastrointestinal Cancers Symposium showed improved performance, with colorectal cancer detection rates of 80.4% to 85% and better detection of advanced precancerous lesions while maintaining 90% specificity.