Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received FDA approval, and Abbott will exclusively commercialize the assay starting this fall. Freenome said the test is for adults 45 years and older at average risk, using a blood draw to detect colorectal cancer signals from cell-free DNA (cfDNA). The FDA decision comes after Freenome’s registrational PREEMPT CRC study and supports Medicare coverage criteria, with Freenome anticipating uptake in clinical guideline pathways. Under an agreement with Abbott, Freenome will receive a $100 million milestone payment tied to commercialization rights. The announcement intensifies competition in the CRC screening market by adding a non-stool option designed to reduce participation barriers for unscreened patients. For the diagnostics industry, the approval also signals continued expansion of cfDNA methylation and AI-driven analytics into mainstream screening workflows.