Guardant Reveal™—fast, tissue-free minimal residual disease (MRD) detection.1
Predict cancer recurrence earlier with the first tissue-free MRD test for colorectal cancer (CRC), also available for breast and lung cancers.1-5
The ultimate power behind cancer testing.
Guardant Reveal is powered by Guardant Infinity—the first and only commercially available platform that unlocks both epigenomics and genomics to transform precision oncology.*
Overview
Key features for Guardant Reveal
MRD detection.1
limit of detection to maximize sensitivity.1
based on methylation to accurately quantify disease burden.1
turnaround time for timely adjuvant decision-making.6†
Impact clinical decisions with tissue-free ctDNA monitoring.1,2
Detect any remaining cancer1,2
MRD detection can identify high-risk patients to help guide clinical decisions in the adjuvant setting.1 With Guardant Reveal, patients receive up to 3 blood draws starting between 3-13 weeks after curative intent therapy.1
Predict cancer recurrence1,2
Guardant Reveal can detect disease recurrence and easily complements standard-of-care monitoring modalities.1‡
| History & physical exam, colonoscopy, CEA, and CT scan.7 | |||||
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |
| Every 3-6 months | Every 6 months | ||||
| History & physical exam, colonoscopy, CEA, and CT scan.6 | |||||
| Year 1 | Year 2 | ||||
| Every 3-6 months | |||||
| Year 3 | Year 4 | Year 5 | |||
| Every 6 months | |||||
| History & physical exam and mammography.8 | |||||
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |
| Every 3-12 months | |||||
| History & physical exam and mammography.7 | |||||
| Year 1 | Year 2 | Year 3 | |||
| Every 3-12 months | |||||
| Year 4 | Year 5 | ||||
| Every 3-12 months | |||||
| History & physical exam and chest CT scan.9 | |||||
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |
| Every 3-6 months | Every 6-12 months | ||||
| History & physical exam and chest CT scan.8 | |||||
| Year 1 | Year 2 | Year 3 | |||
| Every 3-6 months | |||||
| Year 4 | Year 5 | ||||
| Every 6-12 months | |||||
Published clinical insights on Guardant Reveal
Nakamura et al.
Clinical Cancer Research, 2024
Epigenomic-based MRD testing showed high sensitivity and specificity in predicting recurrence in CRC.10
Janni et al.
Cancer Research, 2022
High sensitivity and specificity rates and substantial lead time were shown when predicting recurrence in early-stage breast cancer.3
Parikh et al.
Clinical Cancer Research, 2021
Guardant Reveal is covered by Medicare for patients with stage II or III CRC whose testing is initiated within 3 months following curative intent therapy.
Important note: Guardant Reveal was developed as a Laboratory Developed Test (LDT), 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. This test has not been cleared or approved by the US FDA.
Disclaimer: To qualify for automatic reflex to comprehensive molecular profiling, a patient must have stage II or III cancer, have a positive Guardant Reveal MRD test with a tumor fraction at or above 0.05%, and must not have had a Guardant liquid therapy selection test within the last 45 days. Providers can opt out of this automatic reflex by checking the “Opt out of reflex” box on the Guardant Health Test Requisition Form.
CEA, carcinoembryonic antigen; CRC, colorectal cancer; CT, computerized tomography; ctDNA, circulating tumor DNA.
*Features and methylation components may vary based on final product configuration.
†Median turnaround time from sample receipt to results.
‡For invasive carcinomas and inflammatory breast cancers and non-small cell lung cancer (adenocarcinoma, large cell, and squamous).
References: 1. Guardant Health data on file. October 19, 2023. Guardant Health, Inc. Redwood City, CA. 2. Parikh AR, Van Seventer EE, Siravegna G, et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res. 2021;27(20):5586-5594. doi:10.1158/1078-0432.CCR-21-0410 3. Janni W, Huober J, Braun T, et al. Multiomic, plasma-only circulating tumor DNA (ctDNA) assay identifies breast cancer patients with minimal residual disease (MRD) and predicts distant recurrence. Poster presented at: American Association for Cancer Research Annual Meeting; April 8-13, 2022; Philadelphia, PA. Accessed June 29, 2023. https://doi.org/10.1158/1538-7445.AM2022-3403 4. Nagasaka M, Uddin MH, Al-Hallak MN, et al. Liquid biopsy for therapy monitoring in early-stage non-small cell lung cancer. Mol Cancer. 2021;20(1):82. doi:10.1186/s12943-021-01371-1 5. Larribère L, Martens UM. Advantages and challenges of using ctDNA NGS to assess the presence of minimal residual disease (MRD) in solid tumors. Cancers (Basel). 2021;13(22):5698. doi:10.3390/cancers13225698 6. Guardant Health data on file. September 27, 2024. Guardant Health, Inc. Redwood City, CA. 7. Colorectal cancer: follow-up care. Cancer.Net®. Accessed June 29, 2023. https://www.cancer.net/cancer-types/colorectal-cancer/follow-care 8. American Cancer Society. Living as a breast cancer survivor. Accessed June 29, 2023. https://www.cancer.org/cancer/types/breast-cancer/living-as-a-breast-cancer-survivor.html 9. Schneider BJ, Ismaila N, Aerts J, et al. Lung cancer surveillance after definitive curative-intent therapy: ASCO guideline. J Clin Oncol. 2020;38(7):753-766. doi:10.1200/JCO.19.02748 10. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Colorectal cancer recurrence prediction using a tissue-free epigenomic minimal residual disease assay. Clin Cancer Res. 2024. doi:10.1158/1078-0432.CCR-24-1651