Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received U.S. FDA approval, marking the first commercial use of the company’s AI-enhanced cfDNA methylation approach. The test is designed for adults age 45 and older at average risk and requires only a blood draw. Under a commercialization agreement, Abbott will hold exclusive rights to market SimpleScreen CRC in the U.S. starting this fall. Freenome said the approval supports Medicare coverage criteria and anticipates incorporation into American Cancer Society guidelines. For the biotech and diagnostic ecosystem, the approval highlights continuing momentum for non-invasive liquid biopsy screening offerings, with major medtech distribution partners accelerating access for under-screened populations.