FDA Panel Recommends Approval for Guardant Health’s Colon Cancer Detection Blood Test

An independent panel of advisers to the Food and Drug Administration has recommended that the agency approve Guardant Health’s blood-based colon cancer detection test. This approval would mark an important step in the test’s wider acceptance and use. The panel, comprised of experts, carefully reviewed presentations from Guardant, the FDA, and members of the public before voting on the screening test, known as Shield. Nine panel members then voted on the safety and efficacy of the test, with a majority endorsing its safety, effectiveness, and benefits outweighing its risks.

The approval from the FDA is crucial for gaining coverage from the Centers for Medicare and Medicaid Services (CMS), which could determine the test’s success in becoming widely available. In recent years, CMS has denied coverage for other blood-based colon cancer tests due to their lack of evidence-based practice. This approval marks a turning point for Guardant Health’s Shield test as it continues to gain recognition within the medical community and beyond.

Exclusive to STAT+ subscribers, this article provides insight into the potential impact of this FDA approval on Guardant Health’s colon cancer detection test. Subscribers gain access to daily coverage and analysis of the biotech sector, making it a valuable tool for staying informed in the industry. To unlock this article and more, consider subscribing to STAT+ for unlimited access to award-winning journalism and exclusive events.