SimpleScreen CRC Test Reports Improved Blood-Based Sensitivity

Freenome's updated SimpleScreen™ CRC test reports improved blood-based sensitivity for colorectal cancer—company-reported validation sensitivity was 85% for CRC.

Compared with prior versions and other noninvasive options, the updated assay showed higher CRC sensitivity but only modest detection of advanced precancerous lesions.

Freenome attributed the observed gains to assay refinements—described broadly as algorithm tuning and an expanded marker panel.

Modeled population projections estimate a 9% reduction in lifetime colorectal cancer cases and a 10% reduction in colorectal cancer deaths. Because these are model-based estimates, they depend on real-world factors such as test adoption, adherence to follow-up colonoscopy after a positive result, and the screening intervals used; therefore, the projections are conditional rather than measured outcomes.

Guideline deliberations and practice uptake will require prospective evidence of screening benefit, regulatory review, and payer coverage decisions before major protocol changes. Operational items to monitor include test availability, establishing clear pathways for positive-test follow-up, and how the option is presented in shared-decision conversations about noninvasive screening.