FDA approves Shield blood test for colorectal cancer screening in average-risk adults aged 45 and older (accessdata.fda.gov)

• FDA approved Guardant Health's Shield blood test for colorectal cancer screening in average-risk adults 45+.
• Labeling includes precaution: 55-65% sensitivity for Stage I CRC; 87% of precancerous lesions not detected.
• Mandatory post-approval study to evaluate 3-year longitudinal performance with enrollment and reporting milestones.

"The US FDA approved Guardant Health's Shield blood test for colorectal cancer screening in average-risk individuals aged 45+. The test detects colorectal cancer-derived alterations in cell-free DNA. Positive results require colonoscopy follow-up. Labeling includes a precaution: limited detection (55-65%) of Stage I CRC and failure to detect 87% of precancerous lesions. A post-approval study is mandated to evaluate longitudinal performance over 3 years, with enrollment milestones and reporting requirements. The device has a 12-month shelf life."