Guardant Complete
offers a comprehensive range of precision oncology tests.1-4

Product Selector
Discover all liquid and tissue testing options.

Early
Detection
Treatment
Selection
Monitoring

Guardant Shield


Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

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FDA-Approved Guardant360® CDx1,5 Guardant360®2,6,7 Guardant360
TissueNext™3,8
INFORMATION PROVIDED
FDA-approved
companion diagnostic
with CGP of only 55 genes
Guides treatment
selection with CGP test
of 83 genes
Guides treatment
selection with CGP
of 84 genes
FOR ANY SOLID TUMOR
checked
checked
checked
LIQUID TEST
checked
checked
N/A
MEDICARE COVERAGE
checked
checked
checked
TURNAROUND TIME*
7 days10 days2-3 weeks

Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

CGP, comprehensive genomic profiling.

Guardant Reveal™4,9-11 Guardant360
Response™12
INFORMATION PROVIDED
Detects residual
disease
Measures molecular
response
FOR ANY SOLID TUMOR
Stage II or III colorectal,
breast, and lung cancer
checked
LIQUID TEST
checked
checked
MEDICARE COVERAGE
Stage II or III
colorectal cancer
N/A
TURNAROUND TIME*
2-3 weeks2 weeks

Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

Guardant Shield


Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

SWIPE TO REVEAL FULL TABLE
FDA-Approved Guardant360® CDx1,5 Guardant360®2,6,7 Guardant360
TissueNext™3,8
INFORMATION PROVIDED
FDA-approved
companion diagnostic
with CGP of only 55 genes
Guides treatment
selection with CGP test
of 83 genes
Guides treatment
selection with CGP
of 84 genes
FOR ANY SOLID TUMOR
checked
checked
checked
LIQUID TEST
checked
checked
N/A
MEDICARE COVERAGE
checked
checked
checked
TURNAROUND TIME*
7 days10 days2-3 weeks

Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

CGP, comprehensive genomic profiling.

Guardant Reveal™4,9-11 Guardant360
Response™12
INFORMATION PROVIDED
Detects residual
disease
Measures molecular
response
FOR ANY SOLID TUMOR
Stage II or III colorectal,
breast, and lung cancer
checked
LIQUID TEST
checked
checked
MEDICARE COVERAGE
Stage II or III
colorectal cancer
N/A
TURNAROUND TIME*
2-3 weeks2 weeks

Important Note: The Guardant Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and 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. Shield, Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDT). These tests have not been cleared or approved by the US FDA.

Get critical insights about patients cancer
across the continuum.

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Guardant Reveal Logo

First liquid-only biopsy for minimal residual disease (MRD) detection in early-stage settings.4

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FDA Approved Guardant360 CDx Logo

First FDA-approved liquid-only comprehensive genomic profiling (CGP) for advanced-stage treatment selection.1,5

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Guardant360 TissueNext Logo

Tissue CGP for advanced-stage
treatment selection.3‡

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Guardant360 Response Logo

Liquid-only biopsy that measures treatment response in advanced-stage cancer.12

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Guardant360 Logo

Liquid-only CGP test for treatment selection in patients who have progressed on therapy.2

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Download the guide to order both Treatment Selection and Monitoring tests from Guardant Complete.

*Turnaround times are most current best estimates based on actual sample processing times.

Patient timeline is for illustrative purposes only.

Confirmation of medical necessity is required if Guardant360 TissueNext is ordered with another Guardant Health profiling test.

HRR, homologous recombinational repair; MSI, microsatellite instable; NTRK, neurotrophic tyrosine receptor kinase; PD-L1, programmed death-ligand 1; TMB, tumor mutation burden.

References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Palo Alto, CA. July 2021. 2. Guardant360® Assay Specifications. Guardant Health, Inc. Palo Alto, CA. 3. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Palo Alto, CA. 4. Backgrounder: Guardant Reveal™ liquid biopsy test. Guardant Health, Inc. Palo Alto, CA. 5. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed October 31, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 6. Guardant360. National Library of Medicine. Bethesda, MD. August 2021. 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 November 1, 2022. 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