FDA approves Freenome's SimpleScreen CRC blood test for colorectal cancer screening in adults 45+

The FDA has approved SimpleScreen CRC, a blood-based test developed by Freenome and commercialized by Abbott, for colorectal cancer screening in adults aged 45 and older at average risk. This test offers a convenient alternative to traditional screening methods, detecting colorectal cancer with 81.1% sensitivity and 90.4% specificity. With Medicare coverage and expected inclusion in American Cancer Society guidelines, the test aims to increase screening rates among the 60 million Americans overdue for colorectal cancer screening. Abbott will launch the test in the U.S. this fall, expanding screening options and potentially improving early detection and outcomes.