FDA approves Freenome's SimpleScreen CRC test

The U.S. FDA approved Freenome's blood-based colorectal cancer screening test, SimpleScreen CRC, for average-risk adults aged 45 and older. Abbott will exclusively commercialize the test in the U.S. starting fall 2026, paying Freenome a $100 million milestone payment. The test detects cancer signals from cell-free DNA and demonstrated 81.1% sensitivity for colorectal cancer and 90.4% specificity in the PREEMPT CRC study. It competes with Guardant Health's Shield blood test. The approval meets Medicare coverage criteria and is expected to be included in American Cancer Society guidelines. Up to 60 million Americans are overdue for colorectal cancer screening.