Guardant Health, Inc. announced that its Shield multi-cancer detection (MCD) test received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is granted to devices with the potential to provide more effective treatment or diagnosis of life-threatening diseases than current options.
The Shield MCD test is a methylation-based blood test for multi-cancer screening of multiple cancer types, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancer, in individuals aged 45 or older at typical average risk.
AmirAli Talasaz, Guardant Health co-CEO, stated that this recognition shows the promise of the Shield MCD test to detect multiple cancers at an early stage with a single blood draw. The designation builds on the test's recent selection by the National Cancer Institute (NCI) for the Vanguard Study, further solidifying its potential impact.
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