The FDA approved Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, enabling the company to move from clinical studies to commercial deployment. Freenome said the test is for adults 45 and older at average risk, based on a simple blood draw detecting cell-free DNA signals associated with colorectal cancer. The company also tied the approval to Medicare coverage criteria and anticipated incorporation into American Cancer Society guidelines. Under an agreement with Abbott, Abbott will have exclusive U.S. commercial rights starting this fall, with Freenome eligible for a $100 million milestone tied to commercialization. The decision increases competitive intensity in CRC screening, particularly as blood-based options seek to capture patients not completing stool-based testing programs.