Guardant Health’s Multi-Cancer Detection Test Wins FDA Breakthrough Designation

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Guardant Health Inc.’s Shield multi-cancer detection (MCD) test. The methylation-based blood test screens for numerous cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

The FDA grants Breakthrough Device designation to a limited set of qualifying devices that potentially can provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The Breakthrough Devices Program’s goal is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment ,and review.

“Every late-stage cancer we avert is a win for patients and for the entire healthcare system,” Guardant Health Co-Founder/CEO AmirAli Talasaz said. “This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.”

The Shield MCD test’s Breakthrough Device designation builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin.

At the recent 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on Shield MCD’s clinical validation, showing the blood-based test exhibits high specificity, clinically meaningful sensitivity, and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort indicated the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62%-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%.

Guardant Health is a 13-year-old precision oncology company that is accelerating new cancer therapies by providing critical insights into disease drivers through its advanced blood and tissue tests, real-world data, and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.