FDA-approved Guardant Shield blood test for colorectal cancer screening: performance characteristics and limitations (accessdata.fda.gov)

• Guardant Shield test approved for average-risk CRC screening ages 45+
• Sensitivity for Stage I CRC only 54.5%; misses 87% of advanced precancerous lesions
• False negative rate 17% for CRC; false positive rate 10%
• Positive results require follow-up colonoscopy

"The FDA has approved the Guardant Shield blood test for colorectal cancer screening in average-risk individuals aged 45 and older. The test detects cancer-derived alterations in cell-free DNA from blood. Clinical data show 87.5% sensitivity for colorectal cancer overall, but only 54.5% for Stage I and 13.2% for advanced precancerous lesions. False negative rate for cancer is 17%; false positive rate is 10%. Positive results require follow-up colonoscopy."