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Tuesday, June 3, 2025

FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection

 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

https://finance.yahoo.com/news/fda-grants-breakthrough-device-designation-120500589.html

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