Freenome Reports Top-Line Readout of Updated SimpleScreen™ CRC Colorectal Cancer Screening Blood Test Met All Primary and Secondary Endpoints (Freenome)

Freenome reported positive results from a pivotal clinical validation study of its next-generation SimpleScreen™ CRC blood test, which met all primary and secondary endpoints while significantly improving detection of advanced precancerous lesions (APLs). The updated test achieved 80.4% sensitivity for colorectal cancer, 18.2% sensitivity for advanced precancerous lesions, and 41.9% sensitivity for high-grade dysplasia (HGD)—a substantial improvement over the first-generation test. The company noted that the sensitivity for detecting APLs and HGD is the highest reported to date for any noninvasive blood-based colorectal cancer screening test evaluated in a prospective registrational study.