09:09 AM EDT, 06/03/2025 (MT Newswires) -- Guardant Health ( GH ) said Tuesday its Shield multi-cancer detection test has received breakthrough device designation from the US Food and Drug Administration.

The company said the Shield test is a methylation-based blood test designed to screen for multiple cancers, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreatic, in individuals aged 45 and older at average cancer risk.

The designation is granted to devices with the potential to offer more effective diagnosis or treatment for serious conditions, accelerating development and regulatory review through the FDA's Breakthrough Devices Program.