Guardant Health's Shield Multi-cancer Detection Test Secures FDA's Breakthrough Device Designation

(RTTNews) - Guardant Health, Inc. (GH), Tuesday announced that the company's Shield multi-cancer detection or MCD test, a methylation-based blood test for the multi-cancer screening, has been granted Breakthrough Device designation from the U.S. Food and Drug Administration.

The designation comes as Shield MCD test was chosen by the National Cancer Institute for the Vanguard Study, where the test demonstrated strong performance in predicting the presence of cancers and cancer tissue of origin.

Following this recognition, the company expects to collaborate with FDA and other stakeholders to bring the Shield MCD test to the patients.

In the pre-market hours, GH is trading at $43, up 2.14 percent on the Nasdaq.