FDA Approves Guardant Health Shield Blood Test for Colorectal Cancer Screening in Average-Risk Adults Aged 45 and Older (accessdata.fda.gov)

• Approved for average-risk adults aged 45+; not for high-risk individuals.
• CRC sensitivity 83% overall but only 55% for stage I; advanced adenoma sensitivity 13%.
• False negative rate 17% for CRC; false positive rate 10% for advanced neoplasia.
• Positive result requires colonoscopy; test cannot replace diagnostic colonoscopy.

"The US FDA approved Guardant Health's Shield blood test for colorectal cancer screening in average-risk individuals aged 45 and older. The test detects cell-free DNA alterations from blood samples but has limited sensitivity for stage I cancers (55-65%) and advanced precancerous lesions (13.2%). False negative rate for CRC is 17%, false positive rate 10%. Positive results require follow-up colonoscopy. The test is not for high-risk patients."