Freenome said the FDA has approved its SimpleScreen CRC blood test for colorectal cancer, marking a commercial milestone for blood-based screening using AI and cell-free DNA methylation. The test will be exclusively commercialized in the U.S. by Abbott starting this fall. SimpleScreen is designed for adults 45 and older at average risk and requires a single blood draw. Freenome said the test detects cancer-associated signals from cell-free DNA, with the company estimating that up to 60 million Americans are overdue for recommended CRC screening. Freenome’s deal with Abbott includes a $100 million milestone tied to approval, and the company expects the American Cancer Society to consider the test for guideline inclusion, adding competitive pressure in a screening market dominated by stool-based options.