Guardant Complete is advancing precision oncology with a range of liquid and tissue tests.1-4

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Guardant Shield™
FDA-Approved Guardant360® CDx1,5 | Guardant360®2,6,7 | Guardant360 TissueNext™3,8 | |
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INFORMATION PROVIDED | |||
FDA-approved companion diagnostic with CGP of clinically relevant biomarkers | Guides treatment selection with expanded panel of genes, including NTRK 1-3, HRR, and bTMB | Guides treatment selection with CGP of clinically relevant biomarkers, including TMB, MSI status, and PD-L1 | |
TUMOR TYPE | |||
All solid tumors | All solid tumors | All solid tumors | |
TESTING MODALITY | |||
Liquid | Liquid | Tissue | |
MEDICARE COVERAGE | |||
All solid tumors | All solid tumors | All solid tumors | |
TURNAROUND TIME* | |||
7 days | 10 days | 2-3 weeks | |
Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant Galaxy PD-L1, Guardant360 Response, and Guardant360 tests were developed, and their 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. Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Galaxy PD-L1, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDTs). These tests have not been cleared or approved by the US FDA. |
SWIPE TO REVEAL FULL TABLE
First tissue-free minimal residual disease (MRD) test for colorectal cancer, now available for breast and lung cancers.4,9-11
Explore product ›First FDA-approved liquid-only comprehensive genomic profiling (CGP) for advanced-stage treatment selection.1,5
Explore product ›Liquid-only CGP test for treatment selection in patients who have progressed on therapy.2
Explore product ›Important Note: The Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and their 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. Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDTs). These tests have not been cleared or approved by the US FDA.
*Patient timeline is for illustrative purposes only.
†Confirmation of medical necessity is required if Guardant360 TissueNext is ordered with another Guardant Health profiling test.
References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021. 2. Guardant360® Assay Specifications. Guardant Health, Inc. Redwood City, CA. 3. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Redwood City, CA. 4. Backgrounder: Guardant Reveal™ Liquid Biopsy Test. Guardant Health, Inc. Redwood City, CA. 5. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed June 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 6. National Institutes of Health. Guardant360. National Library of Medicine; Bethesda, MD. Updated August 12, 2021. Accessed June 29, 2023. https://www.ncbi.nlm.nih.gov/gtr/tests/527948 7. Heeke AL, Pishvaian MJ, Lynce F, et al. Prevalence of homologous recombination-related gene mutations across multiple cancer types. JCO Precis Oncol. 2018;2:1-13. doi:10.1200/PO.17.00286 8. Cui W, Milner-Watts C, O'Sullivan H, et al. Up-front cell-free DNA next generation sequencing improves target identification in UK first line advanced non-small cell lung cancer (NSCLC) patients. Eur J Cancer. 2022;171:44-54. doi:10.1016/j.ejca.2022.05.012 9. 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 10. 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 11. 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 12. Zhang Q, Luo J, Wu S, et al. Prognostic and predictive impact of circulating tumor DNA in patients with advanced cancers treated with immune checkpoint blockade. Cancer Discov. 2020;10(12):1842-1853. doi:10.1158/2159-8290.CD-20-0047