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

Reuters
03 Jun
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection Test

Guardant Health Inc., a leading precision oncology company, announced that its Shield Multi-Cancer Detection $(MCD)$ test has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation highlights the potential of the Shield MCD test to provide a more effective diagnosis of multiple cancer types, such as bladder, colorectal, and lung cancer, through a simple blood test. Designed for individuals aged 45 or older who are at average risk of cancer, the Shield MCD test was also selected by the National Cancer Institute for the Vanguard Study due to its strong performance in predicting cancer presence and origin. This recognition by the FDA is expected to accelerate the test's development and availability to patients.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Guardant Health Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250603684215) on June 03, 2025, and is solely responsible for the information contained therein.

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