Guardant Health has announced that its Shield multi-cancer detection (MCD) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
This test, which relies on blood samples and employs methylation analysis, is designed to screen for multiple types of cancer, such as colorectal, bladder, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers.
It is intended for individuals aged 45 and over who are at average risk of developing cancer.
The FDA’s Breakthrough Devices Program is designed to speed up the development and review of innovative medical technologies that may offer more effective diagnosis or treatment for serious conditions.
The designation helps companies work more closely with the agency to bring new solutions to market faster.
The US National Cancer Institute has chosen the Shield test for its Vanguard Study, an initiative aimed at evaluating emerging technologies for multi-cancer detection.
The test was chosen based on its strong performance in identifying the presence and origin of various cancers.
The company aims to make the test available to patients more widely, offering a simple blood draw as a potential option for early detection of multiple cancers.
