Cancer shifts constantly. Completely transform the way you see what’s next, now.
Guardant Complete is a portfolio of revolutionary liquid and tissue precision oncology tests, all with the convenience of a single testing company.1,2
PRODUCT SELECTOR
Featuring a range of testing products for treatment selection, monitoring, and MRD assessment.
Find the right testing options.
SelectionRecurrence
& Response
Monitoring
Guardant Shield™
FDA-Approved Guardant360® CDx1,3 | Guardant360®4-6 | Guardant360 TissueNext™2* | |
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Information Provided | |||
FDA-approved CGP of clinically relevant biomarkers and 5 companion diagnostics. | CGP with an expanded panel of genes, including NTRK1-3,HRR, and bTMB. | Guides treatment selection with tissue CGP panel covering clinically relevant biomarkers, including TMB, MSI status, and PD-L1 | |
Tumor Type | |||
All advanced solid tumors | All advanced solid tumors | All advanced solid tumors | |
Testing Modality | |||
Liquid | Liquid | Tissue | |
Medicare Coverage | |||
All advanced solid tumors | All advanced solid tumors | All advanced solid tumors | |
Turnaround Time* | |||
7 days | 10 days | 2-3 weeks | |
Guardant Reveal™7-10 | Guardant360 Response™11-12 |
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Information Provided | |
Detects minimal residual disease | Measures molecular response to therapy |
Tumor Type | |
Stage II or III colorectal, breast, and lung cancers | All advanced solid tumors |
Testing Modality | |
Liquid | Liquid |
Medicare Coverage | |
For Stage II or III colorectal cancer when testing is initiated within 3 months following curative intent therapy | IO monitoring for all advanced solid tumors |
Turnaround Time* | |
2 weeks | 10 days |
Guardant Complete offers a comprehensive range of liquid and tissue tests for end-to-end insights.
SWIPE TO REVEAL FULL CHART
First tissue-free biopsy for minimal residual disease (MRD) detection in early-stage settings.3
Explore product ›First FDA-approved liquid-only comprehensive genomic profiling (CGP) for advanced-stage treatment selection.1,4
Explore product ›Liquid-only CGP test for treatment selection in patients who have progressed on therapy.6,7
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.
*Confirmation of medical necessity is required if Guardant360 TissueNext is ordered with another Guardant Health profiling test.
†Patient timeline is for illustrative purposes only.
bTMB, blood-based tumor mutation burden; CGP, comprehensive genomic profiling; CRC, colorectal cancer; HRR, homologous recombination repair; MRD, minimal residual disease; MSI, microsatellite instability; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; IO, immunotherapy; PD-L1, programmed death-ligand 1; TMB, tumor mutation burden.
References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. February 2023. 2. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Redwood City, CA. 3. 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 4. Guardant360® Assay Specifications. Guardant Health, Inc. Redwood City, CA. 5. Heeke AL, Pishvaian MJ, Lynce F, et al. Prevalence of homologous recombination-related gene mutations across multiple cancer types. JCO Precis Oncol. 2018;2018:PO.17.00286. doi:10.1200/PO.17.00286 6. Guardant360® Gene Pocket Guide. Guardant Health, Inc. Redwood City, CA. 7. Backgrounder: Guardant Reveal™ liquid biopsy test. Guardant Health, Inc. Redwood City, CA. 8. Data on file. Guardant Reveal on Infinity. Guardant Health, Inc. Redwood City, CA. 9. 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 10. 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 11. 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 12. Guardant360 Response™ Guide to ordering. Guardant Health, Inc. Redwood City, CA. 13. 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 non-small cell lung cancer (NSCLC) patients. Eur J Cancer. 2022;171:44-54. doi:10.1016/j.ejca.2022.05.012