Guardant360® Tissue
Maximum insights. Minimal tissue.
The most advanced multiomic tissue test that delivers DNA, RNA, and epigenomic insights—all with the lowest sample requirements.*1
Overview
Key features for Guardant360 Tissue
a guideline-complete panel, including TMB and MSI.†‡1
with 92% less surface area§ and 75% less tumor cellularity¶ for Guardant360 Tissue vs the industry standard
powered by InfinityAI
Unmatched concurrent liquid and tissue testing.#
Order Guardant360 Tissue with Guardant360 Liquid CDx, now FDA-approved.
Biomarker Panel
Guardant360 Tissue is guideline-complete across all advanced solid tumors.1
Covered clinically-relevant biomarkers for common cancer types
ALK, BRAF, EGFR, ERBB2, FGFR1§§, FGFR2§§, FGFR3§§, FGFR4, KRAS, MET, NRG1, NTRK1, NTRK2, NTRK3, RET, ROS1
AKT1, gBRCA1, gBRCA2, ERBB2, ESR1, FGFR1§§, FGFR2§§, FGFR3§§, NTRK1, NTRK2, NTRK3, PALB2, PIK3CA, PTEN, RET, MSI
BRAF, ERBB2, KRAS, NRAS, NTRK1, NTRK2, NTRK3, RET, MSI
ATM, ATR, BARD1, BRAF V600E, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, FANCL, MLH1, MRE11, NBN, NTRK1, NTRK2, NTRK3, PALB2, RAD51B, RAD51C, RAD51D, RAD54L, RET, MSI, TMB
See the full panel.
Germline results are issued as a separate clinical report.
Enabled Features
Unlock a more comprehensive view of cancer with additional features and epigenomic insights†
Molecular Tumor Type
Utilize epigenomic signatures to help identify tissue of origin.12
Pharmacogenomics
Optimize treatment and reduce toxicity by identifying alleles in CYP2D6, DPYD, UGT1A1, HLA-B, and TPMT.13
HRD Status
Determine status in breast, ovarian, and pancreatic cancers to inform the use of PARP-inhibitor and platinum-based chemotherapies.14
The largest real-world data library with epigenomic and longitudinal signals15
Advanced, domain-specific AI to unlock maximum clinical actionability
Complete insights from novel actionable features for more confident decision-making across the continuum of care.
Guardant® tests‡‡ are covered by all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others, ensuring access for 300 million+ lives.15¶¶
DNA, deoxyribonucleic acid; EBV, Epstein-Barr virus; HLA, human leukocyte antigen; HPV, human papillomavirus; HRD, homologous recombination deficiency; IHC, immunohistochemistry; RNA, ribonucleic acid
*Compared to other leading comprehensive tissue tests. The “most advanced” referring to the first and only commercially available tissue test to deliver multiomic insights from a single input.
‡Guideline complete for genomic biomarkers.
§2mm2 required for Guardant360® Tissue vs 25mm2 industry standard.
¶5% for Guardant360® Tissue vs 20% industry standard.
#Guardant360®® Tissue can be ordered as a standalone or with Guardant360® Liquid CDx biopsy. Liquid and tissue testing may be initiated at the same time, but sample processing does not occur concurrently. Once the Guardant360® Liquid CDx results have been delivered, confirmation of medical necessity is required to proceed with Guardant360® Tissue. Patients who have a negative Guardant360® Liquid CDx test result for an indicated companion diagnostic marker should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible.
||Covers all biomarkers associated with FDA-approved therapies in prostate cancer.
**Blood sample is required for germline testing.
††The only real-world data to include NGS epigenomic results from >400,000 patients
‡‡Refers to Guardant360® Liquid CDx.
§§FGFR1, FGFR2, and FGFR3 are designated as emerging biomarkers in guidelines and are not associated with an agent with an FDA indication for lung and breast cancers.
¶¶Non-unique lives covered across Guardant360 Liquid CDx and Guardant360 Tissue, including overlap across tests and payers.
For a full list of diagnoses, download the Controlled Language for Diagnosis page.
Important note: Guardant360® Tissue and Guardant Hereditary Cancer were developed as Laboratory Developed Tests (LDT), 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. These tests have not been cleared or approved by the US FDA.
InfinityAI is not a standalone customer product. “Powered by InfinityAI” refers to Guardant Health artificial intelligence and machine learning technology used in development of product features. These features are reported as professional service and have not been cleared or approved by the US FDA. For a full list of diagnoses, download the Controlled Language for Diagnosis page.
References: 1. Guardant360® Tissue Assay Specifications. 2025. POL-000127. Guardant Health, Inc. Redwood City, CA. 2. Clemens K, Bucheit L, Forbes S, Alshurafa H, Das A, Eltoukhy H. Exploring clinical actionability of expanded liquid biopsy in advanced breast and colorectal cancers. Abstract 6512. Cancer Res. 2026;86(7 suppl):6512. doi.org/10.1158/1538-7445.AM2026-6512 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2026.© National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 18, 2026 To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2026.. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 18, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed May 18, 2026 To view the most recent and complete version of the guideline, go online to NCCN.org. 6. Lynparza (olaparib) prescribing information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2025. https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf 7. Talzenna (talazoparib) prescribing information. New York, NY: Pfizer Inc; June 2025. https://labeling.pfizer.com/ShowLabeling.aspx?id=20582 8. Vitrakvi (larotrectinib) prescribing information. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2025. https://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf 9. Keytruda (pembrolizumab) prescribing information. Rahway, NJ: Merck & Co, Inc; February 2026. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 10. Retevmo (selpercatinib) prescribing information. Indianapolis, IN: Eli Lilly and Company; November 2025. https://uspl.lilly.com/retevmo/retevmo.html#pi 11. Tafinlar (dabrafenib) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2025. https://www.novartis.com/us-en/sites/novartis_us/files/tafinlar.pdf 12. Forouzmand E, Lawrence L, Tung J, et al. A methylation-based molecular tumor typing classifier for tissue samples from cancers of unknown primary. Abstract presented at: 117th Annual Meeting of the American Association for Cancer Research; April 17–22, 2026; San Diego, CA. 13. Nogueiras-Álvarez R, Pérez Francisco I. Pharmacogenetics in oncology: a useful tool for individualizing drug therapy. Br J Clin Pharmacol. 2024;90(10):2483-2508. doi:10.1111/bcp.16181 14. Safabakhsh P, Tolkunov D, Overstreet B, et al. Tissue-based homologous recombination deficiency status prediction in patients with breast, ovarian, and pancreatic cancers. Abstract presented at: 117th Annual Meeting of the American Association for Cancer Research; April 17–22, 2026; San Diego, CA. 15. Guardant Health data on file. 2026. Guardant Health, Inc. Redwood City, CA.