Guardant Health Inc. (NASDAQ:GH) saw its stock rise by 3.7% after announcing that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its Shield multi-cancer detection (MCD) test. This blood-based screening tool is designed to identify multiple types of cancer in adults aged 45 and older who are considered at average risk.
The FDA’s Breakthrough Devices Program is intended to accelerate the development and evaluation of technologies that could offer substantial advancements in diagnosing or treating life-threatening illnesses. Guardant Health’s Shield MCD test is engineered to detect a wide range of cancers, including lung, liver, pancreatic, ovarian, esophageal, colorectal, bladder, and gastric cancers – potentially offering a more accessible and non-invasive method for early detection.
AmirAli Talasaz, co-founder and co-CEO of Guardant Health, highlighted the importance of early detection in improving survival rates and reducing the burden on healthcare systems. He expressed optimism about collaborating with the FDA to fast-track access to the Shield test for patients nationwide.
The FDA designation adds to growing momentum behind Shield, which was also selected by the National Cancer Institute (NCI) for its Vanguard Study – a national effort to assess emerging technologies in multi-cancer detection. Shield was chosen based on its strong performance in identifying cancer presence and pinpointing tissue origin.
At this year’s ASCO Annual Meeting in Chicago, Guardant Health shared new clinical validation results demonstrating Shield’s effectiveness. The test achieved 98.6% specificity and 75% overall sensitivity, with individual cancer sensitivity ranging from 62% to 96%. It also correctly identified the tissue of origin in 92% of cases, underscoring its diagnostic precision.
The market’s positive reaction reflects investor confidence in the test’s potential to revolutionize cancer screening and change the landscape of early diagnosis for high-impact diseases.