In a case-control cohort, Guardant Health’s Shield multi-cancer detection test demonstrated 98.6% specificity and 75% sensitivity across eight tumor types. The test has since received FDA Breakthrough Device designation.

The methylation-based blood assay is designed for screening multiple cancer types—specifically bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers—in asymptomatic adults aged 45 years or older at average risk.

The Breakthrough Devices Program facilitates the development and regulatory review of technologies that may offer more effective diagnostic or therapeutic options for serious conditions. Shield’s designation follows its recent selection by the National Cancer Institute for inclusion in the Vanguard Study, which is evaluating emerging multi-cancer detection (MCD) technologies. The test was selected based on its analytic performance in detecting malignancies and identifying cancer signal origin.

Data presented by Guardant Health at the 2025 American Society of Clinical Oncology Annual Meeting support the clinical validity of the Shield MCD test. In addition to the high specificity and sensitivity in the case-control cohort, the assay demonstrated sensitivity by cancer type that ranged from 62% to 96%. Accuracy for determining primary or secondary cancer signal origin was reported at 92%.

"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,” said AmirAli Talasaz, cofounder and cochief executive officer of Guardant Health.

Source: Guardant Health