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

• FDA approved Guardant Health Shield blood test for colorectal cancer screening in average-risk individuals 45+.
• Test detects tumor-derived DNA methylation and hemoglobin in cell-free DNA.
• Positive results require follow-up colonoscopy; not for high-risk surveillance.
• Approval based on clinical trial NCT04136002; post-approval study mandated.

"The U.S. FDA granted premarket approval (PMA P230009) on July 26, 2024, for Guardant Health's Shield blood test, a qualitative in vitro diagnostic that detects colorectal cancer-derived DNA methylation and hemoglobin in cell-free DNA from blood. It is indicated for screening individuals at average risk, age 45+, and positive results require follow-up colonoscopy. The test is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals. The approval includes post-approval study requirements and labeling restrictions."