Freenome said the FDA approved its SimpleScreen CRC blood-based colorectal cancer screening test, enabling commercialization plans with Abbott under an exclusive U.S. arrangement. The company’s test is intended for average-risk adults starting at age 45 and uses cell-free DNA signals and AI-enhanced accuracy. Freenome reported that it secured Medicare coverage criteria and expects professional guideline consideration, noting the premarket decision was supported by data from the PREEMPT CRC prospective registrational study. Abbott will exclusively commercialize the test beginning this fall, with Freenome set to receive a $100 million milestone tied to the partnership terms. The approval matters for biotech diagnostics as it offers another pathway to scale population screening beyond stool testing, potentially expanding the addressable market for precision, blood-based early detection tools.