Guardant's blood-based Shield screening test for colorectal cancer (CRC) has received the recommendation of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee, an important milestone on its path to approval.
Guardant submitted a premarket approval application for Shield to the FDA in March 2023. The majority of advisory committee members voted to recognize the Shield test's safety and effectiveness with its proposed intended use, concluding that its benefits as a primary noninvasive screening option outweigh any potential risks.
The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication as a primary CRC screening test in adults age 45 and older at average risk for the disease. They voted favorably eight to one on the question that there is reasonable assurance that Shield is safe, six to three in favor of there being reasonable assurance that Shield is effective, and seven to two in favor of the benefits of Shield outweighing its risks.
The Shield test is designed to detect alterations caused by CRC in cell-free DNA from a blood sample, with testing performed at Guardant's lab. It is not intended as a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
