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

PRODUCT SELECTOR

Discover all liquid and tissue testing options.

Early DetectionTreatment
SelectionMonitoring

Guardant Shield™

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.

bTMB, blood-based tumor mutation burden; CGP, comprehensive genomic profiling; HRR, homologous recombination repair; IO, immunotherapy; MSI, microsatellite instability; NTRK, neurotrophic tyrosine receptor kinase.

FDA-Approved

Guardant360® CDx1,5

Guardant360®2,6,7

Guardant360 TissueNext™3,8

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 tumorsAll solid tumorsAll solid tumors
TESTING MODALITY
LiquidLiquidTissue
MEDICARE COVERAGE
All solid tumorsAll solid tumorsAll solid tumors
TURNAROUND TIME*
7 days10 days2-3 weeks
Explore product
Explore product
Explore product

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.

bTMB, blood-based tumor mutation burden; CGP, comprehensive genomic profiling; HRR, homologous recombination repair; IO, immunotherapy; MSI, microsatellite instability; NTRK, neurotrophic tyrosine receptor kinase.

SWIPE TO REVEAL FULL TABLE

Guardant Reveal Logo

First tissue-free minimal residual disease (MRD) test for colorectal cancer, now available for breast and lung cancers.4,9-11

Explore product ›
Guardant 360 CDX Logo w Red Outline

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

Explore product ›
Guardant 360 Tissue Next Logo

Tissue CGP for advanced-stage
treatment selection.3†

Explore product ›
Guardant 360 Response Logo

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

Explore product ›
Guardant 360 Logo

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