The Food and Drug Administration (FDA) this week approved a blood test for colorectal cancer screening in average-risk adults aged 45 and older. Known as Shield, it is the first blood test to receive FDA approval as a primary screening method for colorectal cancer and to qualify for Medicare reimbursement, according to a press release. While the price has not been announced, the test is expected to reach the market within a week. Shield will add to other existing screening options, such as colonoscopies and at-home stool tests, providing patients with more choices. The hope is that a simple blood test at an office visit could offer a more convenient screening alternative for some patients.
How good is it? The test was developed over 10 years, and it demonstrated 83% sensitivity for the detection of colorectal cancer with 90% specificity for advanced neoplasia in clinical trials. Shield’s maker, Guardant Health, Inc., notes that the colorectal cancer screening rate in the United States is only about 59%, and the new test could improve those numbers.