Clinically validated to predict recurrence with high sensitivity and specificity across the most common breast cancers.

In a study of ER+/HER2−
100%
specificity1
100%
sensitivity‡1
In a study of TNBC patients
>99%
specificity*2
83%
sensitivity†2
Other Findings:
✓ Up to 100% positive predictive value1
✓ Up to 2-year lead time to clinical recurrence1

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TNBC = Triple-Negative Breast Cancer;
*Among 69 patients with 198 samples without recurrences; †Among 85 patients with 242 samples, 6 with recurrences;
‡Among patients with ER+ BC (8/8) all with distant recurrence
1. Elliott MJ, Kim J, Dou A, et al. Comprehensive tumor-agnostic evaluation of genomic and epigenomic-based approaches for the identification of circulating tumor DNA in early breast cancer. ESMO Open. . 2025.
2. Ademuyiwa FO, Ma CX, Weilbaecher K, et al. Detection of Circulating Tumor DNA Using a Tissue-Free Epigenomic Assay Is a Highly Prognostic Biomarker in EarlyStage Triple-Negative Breast Cancer. Clin Cancer Res. 2025.
Guardant Reveal was developed as Laboratory Developed Tests (LDTs) and its performance characteristics determined by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The test has not been cleared or approved by the US FDA or by EU/UK Notified Body.
Product availability may vary depending on country / region. Guardant Reveal is not approved nor marketed in the EU.