Freenome wins FDA approval for SimpleScreen CRC blood test for colorectal cancer

The US FDA on 27 July 2026 approved Freenome's SimpleScreen CRC , a blood-based screening test for colorectal cancer in average-risk adults aged 45 and older — offering a needle-based alternative for people who avoid colonoscopy or stool-based tests.

In a prespecified analysis adjusted to the age and sex distribution of the US population, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and demonstrated 90.4% specificity for advanced colorectal neoplasia. Sensitivity for advanced precancerous lesions was 13.7% overall, rising to 30.7% for those with high-grade dysplasia. Freenome said the test correctly detected roughly eight in ten colorectal cancers while returning negative results for about nine in ten people without cancer or advanced precancerous lesions.

The test, built on Freenome's multiomics platform and machine-learning models, will be commercialised exclusively in the US by Abbott under a 2025 agreement that includes a $100 million payment to Freenome. Freenome said SimpleScreen CRC meets Medicare coverage criteria and is expected to be incorporated by name into American Cancer Society screening guidelines.