Guardant360 TissueNext™—the only comprehensive tissue test that improves PD‑L1 detection by >20%.1,2*

With AI-powered precision to better predict treatment outcomes.1-3

icon

Overview

Key features for Guardant360 TissueNext

498 GENES

including those recommended by guidelines.1,4-7†

>20%

improved PD-L1 detection with AI-powered scoring.1,2*

11 day

turnaround time and can be ordered with liquid for concurrent testing.8‡§

0 COST

for Medicare patients.

icon

Biomarker Panel

Guardant360 TissueNext covers guideline-recommended biomarkers across advanced solid tumors.1,4-7

Covered guideline-recommended biomarkers for common cancer types:

Lung

ALK, BRAF, EGFR, ERBB2, KRAS, MET, NTRK1, NTRK2, NTRK3, RET, ROS1, PD-L1

Breast

AKT1, BRCA1, BRCA2, ERBB2, ESR1, NTRK1, NTRK2, NTRK3, PALB2, PIK3CA, PTEN, RET, MSI, PD-L1, TMB

Colorectal

BRAF, ERBB2, KRAS, NRAS, NTRK1, NTRK2, NTRK3, POLD1, POLE, RET, MSI

Prostate

ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCA, FANCL, MLH1, MRE11, NBN, PALB2, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, RB1, TP53, MSI, TMB

Download the full panel to see all 498 genes covered.1

Guardant360 tests are covered across 300 million lives with all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others.

Important note: Guardant360 TissueNext was developed as a Laboratory Developed Test (LDT), and its 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. This test has not been cleared or approved by the US FDA.

AI, artificial intelligence; MSI, microsatellite instability; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; TMB, tumor mutation burden.

*Compared to manual pathologist interpretation in the most challenging cases of NSCLC.

†Guardant360 TissueNext PD-L1 test is powered by Guardant Galaxy and is available for multiple tumor types, including breast, colorectal, gastric, hepatobiliary, lung, pancreatic, prostate, and urothelial cancers. Some cases may require conventional determination of PD-L1 status without AI.

‡Median turnaround time from sample receipt to results.

§Guardant360 TissueNext can be ordered as a standalone or with Guardant360 CDx liquid biopsy. Liquid and tissue testing may be initiated at the same time, but sample processing does not occur concurrently. Once the Guardant360 CDx liquid results have been delivered, confirmation of medical necessity is required to proceed with Guardant360 TissueNext. Patients who have a negative Guardant360 CDx test result for an indicated companion diagnostic biomarker should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible.

For a full list of diagnoses, download the Controlled Language for Diagnosis page. 

References: 1. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Redwood City, CA. 2. Choi S, Cho SI, Ma M, et al. Artificial intelligence–powered programmed death ligand 1 analyser reduces interobserver variation in tumour proportion score for non–small cell lung cancer with better prediction of immunotherapy response. Eur J Cancer. 2022;170:17-26. doi:10.1016/j.ejca.2022.04.011 3. Rodríguez-Abreu D, Powell SF, Hochmair MJ, et al. Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189. Ann Oncol. 2021;32(7):881-895. doi:10.1016/j.annonc.2021.04.008 4. Riely GJ, Wood DE, Ettinger DS, et al. NCCN Guidelines® Insights: Non-Small Cell Lung Cancer, Version 5.2024, NCCN clinical practice guidelines in oncology. Accessed July 17, 2024. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf 5. Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 2.2024, NCCN clinical practice guidelines in oncology. Accessed July 17, 2024. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf 6. Benson AB, Venook AP, Adam M, et al. NCCN Guidelines® Insights: Colon Cancer, Version 3.2024, NCCN clinical practice guidelines in oncology. Accessed July 17, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf 7. Schaeffer EM, Srinivas S, Adra N, et al. NCCN Guidelines® Insights: Prostate Cancer, Version 4.2024, NCCN clinical practice guidelines in oncology. Accessed July 17, 2024. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf 8. Guardant Health data on file. September 27, 2024. Guardant Health, Inc. Redwood City, CA.