Biotech & Genomic Medicine▲impact 4
FDA Approves Freenome's SimpleScreen CRC Blood Test, Abbott to Commercialize in the U.S.
The U.S. Food and Drug Administration has approved Freenome's SimpleScreen CRC, a blood-based screening test for colorectal cancer in adults 45 and older at average risk, with Abbott set to exclusively commercialize the test in the U.S. this fall. The approval triggers a $100 million milestone payment from Abbott to Freenome under their August 2025 commercial agreement. In the PREEMPT CRC study, the largest prospective validation study for a blood-based colorectal cancer screening test, SimpleScreen CRC demonstrated 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. The test meets Medicare coverage criteria and is expected to be incorporated into American Cancer Society guidelines by name, expanding access for up to 60 million Americans who are overdue for screening. Freenome plans to include SimpleScreen CRC in its broader SimpleScreen portfolio while advancing additional single- and multi-cancer tests on the same multiomics platform.