FDA Backs Shield Test for Broad Early Cancer Screening: Daily Dose

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On June 4, 2025, we reported that the US FDA granted Breakthrough Device designation to the Shield multi-cancer detection (MCD) test (Guardant Health).

The approval

Supporting the breakthrough designation, Guardant presented clinical validation data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the test’s high specificity, robust sensitivity, and accurate identification of cancer signal origin (CSO) across a range of tumor types. In a blinded, case-control study of 962 participants, the test achieved an overall specificity of 98.6% and a sensitivity of 59.7% across the 10 cancer types included in the CSO model. Primary or secondary CSO prediction was 92% accurate for those cancers.

The Shield test uses a next-generation sequencing-based epigenomic hybrid capture assay to measure DNA methylation patterns associated with malignancy. A 2-stage classification algorithm first distinguishes cancer from non-cancer samples and then predicts the tissue of origin for cancer-positive cases.

A prospective interventional study is currently underway to evaluate real-world feasibility, and the test has also been selected for use in the National Cancer Institute’s Vanguard Study, a large-scale evaluation of emerging MCD technologies.

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