Guardant360® Liquid CDx
FDA-approved #1 liquid biopsy*1
The only liquid profiling test with genome-wide methylation coverage for enhanced clinical actionability*2,3
Overview
Key features for Guardant360 Liquid CDx
a guideline-complete panel, including TMB and MSI*†4
Detect variants as low as 0.001% MAF‡4
turnaround time for fast results§
powered by InfinityAI
Unmatched concurrent liquid and tissue testing.¶
Order Guardant360 Liquid CDx with the most advanced tissue test, Guardant360 Tissue.#
Multiple FDA-approved companion diagnostics across NSCLC, breast cancer, and colorectal cancer.4-8
Identify actionable biomarkers to match patients with targeted therapies.4-9
| Indication | Biomarker | Therapy |
|---|---|---|
| Breast cancer | ||
| Breast cancer | ESR1 E380, V422del, S463, L469, L536, Y537, and D538 mutations | INLURIYO™ (imlunestrant) |
| ESR1 missense mutations between codons 310-547 | ORSERDU™ (elacestrant) | |
| Indication | Biomarker | Therapy |
|---|---|---|
| Colorectal cancer | ||
| Colorectal cancer | BRAF v600E | BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) |
| Indication | Biomarker | Therapy |
|---|---|---|
| Lung cancer | ||
| Lung cancer | EGFR exon 19 deletions, L858R, and T790M | TAGRISSO® (osimertinib)|| |
| EGFR exon 20 insertions | RYBREVANT® (amivantamab-vmjw) | |
| KRAS G12C | LUMAKRAS™ (sotorasib) | |
| ERBB2/HER2 activating mutations (SNVs and exon 20 insertions) | ENHERTU® (fam-trastuzumab deruxtecan-nxki) | |
Chart is adapted from the Guardant360 Liquid CDx Technical Information.
Biomarker Panel
Guardant360 Liquid CDx is guideline-complete across all advanced solid tumors.†4
Covered clinically-relevant biomarkers for common cancer types
ALK, BRAF, EGFR, ERBB2, FGFR1¶¶, FGFR2¶¶, FGFR3¶¶, KRAS, MET, NRG1, NTRK1, NTRK2, NTRK3, RET, ROS1
AKT1, gBRCA1, gBRCA2, ERBB2, ESR1, FGFR1¶¶,, FGFR2¶¶,, FGFR3¶¶,, NTRK1, NTRK2, NTRK3, PALB2, PIK3CA, PTEN, RET, MSI*, TMB*
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.
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.19
Pharmacogenomics
Optimize treatment and reduce toxicity by identifying alleles in CYP2D6, DPYD, UGT1A1, HLA-B, and TPMT.9
HRD Status
Determine status in breast, ovarian, prostate, and pancreatic cancers to inform the use of PARP-inhibitor and platinum-based chemotherapies.20
Methylation-based
ALK fusion detection
Enhanced detection of ALK fusions in liquid biopsy to help inform use of ALK inhibitor therapy selection3
The largest real-world data library with epigenomic and longitudinal signals21
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.21##
ctDNA, circulating tumor DNA; CUP, cancer of unknown primary; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; MAF, mutant allele fraction; MSI, microsatellite instability; SNV, single-nucleotide variant; TMB, tumor mutation burden; TNBC, triple-negative breast cancer.
*Statement applies to Guardant360 Liquid LDT as reported in a professional service report, which is part of Guardant360 Liquid CDx. The professional service report is not reviewed nor approved by the FDA. #1 liquid biopsy statement is based on stated brand utilization from a market research survey.
†For genomic biomarkers.
‡Reporting thresholds for SNVs.
§Median turnaround time from sample receipt to results.
¶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.
#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.
||The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative, or unknown population, and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.
**Covers all biomarkers associated with FDA-approved therapies in prostate cancer.
††Offered by professional services only.
‡‡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 was developed as a Laboratory Developed Test (LDTs), 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.
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.
References: 1. Guardant Health Data on file. Late-stage Chart Audit. April 2026. 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. Tung L, Valouev A, Odegaard J, et al. Fusion epigenotyping using cell-free DNA methylation improves detection of actionable ALK fusions in non-small cell lung cancer . Abstract presented at: American Association for Cancer Research Annual Meeting; April 20, 2026; San Diego, CA. Abstract 1409 4. Guardant360® Liquid CDx Assay Specifications. April 2026. Guardant Health, Inc. Redwood City, CA. 5. 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 June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf 6. Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 2.2024. NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf 7. Benson AB, Venook AP, Almahdi M, et al. NCCN Guidelines® Insights: Colon Cancer, Version 3.2024. NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf 8. Schaeffer EM, Srinivas S, Adra N, et al. NCCN Guidelines® Insights: Prostate Cancer, Version 4.2024. NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf 9. 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 10. 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. 11. 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. 12. 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. 13. Lynparza (olaparib) prescribing information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2025. https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf 14. Talzenna (talazoparib) prescribing information. New York, NY: Pfizer Inc; June 2025. https://labeling.pfizer.com/ShowLabeling.aspx?id=20582 15. Vitrakvi (larotrectinib) prescribing information. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2025. https://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf 16. Keytruda (pembrolizumab) prescribing information. Rahway, NJ: Merck & Co, Inc; February 2026. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 17. Retevmo (selpercatinib) prescribing information. Indianapolis, IN: Eli Lilly and Company; November 2025. https://uspl.lilly.com/retevmo/retevmo.html#pi 18. Tafinlar (dabrafenib) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2025. https://www.novartis.com/us-en/sites/novartis_us/files/tafinlar.pdf 19. Forouzmand E, He Y, Gittelman R, et al. A novel methylation-based classifier to identify cancer signal of origin using blood-based testing. Abstract 6365. Cancer Res. 2025;85(8_suppl_1):6365. doi:10.1158/1538-7445.AM2025-6365 20. Safabakhsh P, Tolkunov D, Overstreet B, et al. HRD status prediction in patients with advanced breast, prostate, ovarian and pancreatic cancers in a liquid biopsy assay. J Clin Oncol. 2025;43(16_suppl):3074. doi:10.1200/JCO.2025.43.16_suppl.3074 21. Guardant Health data on file. 2026. Guardant Health, Inc. Redwood City, CA.