Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received FDA approval, positioning the assay as a complementary option to stool-based screening. The company said the test is for average-risk adults age 45 and older and uses a blood draw to detect colorectal cancer-associated signals from cell-free DNA. Freenome added that the FDA approval also helps it meet Medicare coverage criteria, and that it expects the American Cancer Society to incorporate the test into guidelines by name. Under its agreement with Abbott, Abbott will exclusively commercialize the test in the U.S. starting this fall, while Freenome is set to receive a $100 million milestone tied to exclusive commercialization rights. The approval follows PREEMPT CRC prospective registrational work and extends Freenome’s Personalized Cancer Detection strategy that pairs cfDNA methylation signals with AI-enhanced accuracy. For the screening market, it adds another blood test competitor in a space where uptake has depended heavily on patient completion and payer coverage. With large segments of the screening-eligible population still overdue, FDA clearance shifts the immediate question from feasibility to real-world adoption and scale-up in clinical laboratories.