PRODUCT SELECTOR

Featuring a range of testing products for treatment selection, monitoring, and MRD assessment.

Find the right testing options.

Early DetectionTreatment
Selection
Recurrence
& Response
Monitoring

Guardant Shield


FDA-Approved

Guardant360® CDx1,3

Guardant360®4-6

Guardant360 TissueNext™2*

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 tumorsAll advanced solid tumorsAll advanced solid tumors

Testing Modality

LiquidLiquidTissue

Medicare Coverage

All advanced solid tumorsAll advanced solid tumorsAll advanced solid tumors

Turnaround Time*

7 days10 days2-3 weeks

Guardant Reveal™7-10

Guardant360 Response™11-12

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

LiquidLiquid

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 weeks10 days

Important Note: The 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 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.

Guardant Complete offers a comprehensive range of liquid and tissue tests for end-to-end insights.

SWIPE TO REVEAL FULL CHART

Guardant Reveal Logo

First tissue-free biopsy for minimal residual disease (MRD) detection in early-stage settings.3

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Guardant360 CDx Logo

First FDA-approved liquid-only comprehensive genomic profiling (CGP) for advanced-stage treatment selection.1,4

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Guardant360 TissueNext Logo

Tissue CGP for advanced-stage treatment selection.2†

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Guardant360 Response Logo

Liquid-only biopsy that measures treatment response in advanced-stage cancer.5

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Guardant360 Logo

Liquid-only CGP test for treatment selection in patients who have progressed on therapy.6,7

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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