The FDA advisory committee is meeting today to review a new blood test developed by Guardant Health that checks for colorectal cancers. The Shield test has shown promising results in clinical trials, with an 83% sensitivity in detecting colorectal cancers and an 88% sensitivity in detecting early-stage cancers. This test works by identifying cancer signals in DNA shed by tumors in the blood stream.
If approved, this would be the first blood test for colorectal cancer that qualifies for Medicare reimbursement, increasing access to screening for more patients. Colorectal cancer is the second leading cause of cancer-related deaths in the US, after lung cancer. Despite its high fatality rate, many eligible individuals do not undergo recommended screenings. The results of the Shield test’s clinical trials have been met with enthusiasm, as it provides an additional screening option that could help close the screening gap and detect colorectal cancer in its early, more treatable stages. Chris Evans, president of the Colon Cancer Coalition, expressed optimism about the potential of the Shield test to increase screening rates and save lives. Trading of Guardant Health’s stock has been temporarily paused as the committee reviews the premarket approval application for the Shield test.
