FDA Approves SimpleScreen Blood Test for Colorectal Cancer Screening

The FDA has approved SimpleScreen CRC (Freenome), a blood-based screening option for colorectal cancer (CRC) in adults aged 45 and older who are at average risk for the disease. Abbott plans to commercialize the test later this fall. The test detects signals associated with CRC from cell-free DNA in the blood and demonstrated a sensitivity of 81.1% for CRC detection in a prespecified analysis from the PREEMPT CRC study.