- Guardant Health's (GH, Financial) Shield multi-cancer detection test receives FDA Breakthrough Device designation.
- The test offers a non-invasive blood-based screening for various cancers in individuals over 45.
- Shield MCD test was highlighted at the 2025 ASCO Annual Meeting for its high specificity and cancer detection accuracy.
Guardant Health, Inc. (GH), a prominent company in precision oncology, announced that the U.S. Food and Drug Administration (FDA) has awarded its Shield multi-cancer detection (MCD) test with the prestigious Breakthrough Device designation. This recognition underscores the Shield MCD test’s potential to enhance early-stage cancer detection, providing a non-invasive screening method through a blood test for several cancer types, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers.
The FDA’s Breakthrough Devices Program aims to expedite the development and evaluation of medical technologies that offer substantial advancements in the diagnosis or treatment of life-threatening conditions. The Shield MCD test caters to adults 45 and older who are at average risk of cancer, aiming to increase early detection and improve patient outcomes.
At the recent American Society for Clinical Oncology (ASCO) Annual Meeting, Guardant Health presented data highlighting the Shield MCD test’s impressive performance. According to the clinical validation study, the test demonstrated a specificity of 98.6% and a cancer sensitivity of 75%, with sensitivity varying from 62% to 96% across different cancer types. The cancer signal of origin accuracy stood at 92%, showcasing the test's efficacy in predicting cancer presence and origin.
Guardant Health continues to build on this momentum, following the Shield MCD test's selection for the National Cancer Institute's Vanguard Study. The company remains committed to working alongside the FDA and healthcare stakeholders to make this breakthrough technology accessible to patients, marking a significant leap in the fight against cancer.
