The Food and Drug Administration (FDA)’s Medical Devices Advisory Committee voted in favor of the approval of a novel blood test to screen for colorectal cancer. Guardant Health’s Shield™ blood test for colorectal cancer screening is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Findings showed the sensitivity of the Shield test was 83.1% (95% CI, 72.2-90.3) for detecting colorectal cancer and 87.5% (95% CI, 75.3-94.1) for detecting pathology-confirmed stages I-III colorectal cancer. Results also showed the Shield test had 89.6% (95% CI, 88.8-90.3) specificity for advanced neoplasia and 89.9% (95% CI, 89.0-90.7) specificity for negative colonoscopy. Overall, the performance of the test was found to be within range of existing stool-based colorectal screening tests.