FDA Approves Freenome's SimpleScreen CRC Blood-Based Test for Colorectal Cancer Screening
The U.S. Food and Drug Administration (FDA) has approved Freenome's SimpleScreen CRC, a blood-based screening test for colorectal cancer (CRC) in adults aged 45 and older who are at average risk. This test, which will be commercialized by Abbott in the U.S., offers a new option for CRC screening that requires only a simple blood draw. The approval follows extensive clinical research and collaboration, including the PREEMPT CRC study, which enrolled over 48,000 participants. SimpleScreen CRC demonstrated 81.1% sensitivity in detecting colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. The test aims to increase screening rates among the estimated 60 million Americans overdue for CRC screening. 
