FDA approves Freenome’s blood test for colorectal cancer screening (Reuters)

The FDA has approved Freenome’s SimpleScreen CRC, a blood-based colorectal cancer screening test that will be exclusively commercialized by Abbott in the U.S. for average-risk adults aged 45 and older. The approval expands noninvasive screening options for the estimated 60 million Americans who are overdue for colorectal cancer screening, although colonoscopy and stool-based tests remain the preferred screening methods. Clinical data showed the test detected 81.1% of colorectal cancers with 90.4% specificity for advanced colorectal neoplasia, positioning it to compete with Guardant Health’s Shield blood test in the growing blood-based cancer screening market.