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

• Approved for average-risk adults 45+; detects colorectal cancer via blood-based DNA analysis.
• Clinical study (n=7,861) showed 83% sensitivity for colorectal cancer; 10% false positive rate for advanced neoplasia.
• Positive results require diagnostic colonoscopy; negative results do not replace routine screening.

"The U.S. FDA approved Guardant Health's Shield blood test for colorectal cancer screening in adults aged 45+ with average risk. The test detects DNA mutations, methylation, and fragmentation patterns from tumor DNA in blood. In a clinical study of 7,861 people, it detected colorectal cancer 83% of the time, with a 10% false positive rate for advanced neoplasia. It is not a replacement for diagnostic colonoscopy."