FDA Approves Blood Test for Colorectal Cancer

The FDA has approved the Shield blood test by Guardant Health as a primary screening tool for colorectal cancer, targeting average-risk adults aged 45 and older. This test, which detects DNA shed by tumors through a simple blood draw, aims to improve low screening rates for colorectal cancer, the second leading cause of cancer-related death in the U.S. Previously costing nearly $900 out of pocket, the FDA approval is expected to enhance insurance coverage, particularly for Medicare beneficiaries. Although the Shield test is not a substitute for colonoscopies, it offers a less invasive option that could encourage more people to get screened. Clinical trials showed an 83% sensitivity rate in detecting colorectal cancer, although it is more effective for later-stage cancers and does not detect early-stage polyps effectively. Experts believe that increasing accessibility to such screening methods could significantly lower colorectal cancer mortality rates.