
decision-making with a dynamic view of cancer.1
- >1 million unique patient profiles
- >350,000 epigenomic profiles
- 150+ tumor types
- EMR data integration and data partnerships providing comprehensive clinical context
Compared with normal cells, cancer cells exhibit a distinct methylation pattern. InfinityAI maps the unique epigenomic fingerprint of cancer by examining differences in these methylation patterns to help detect cancer recurrence sooner and provide insights to improve therapy selection.
The InfinityAI-powered capabilities of Guardant360® Liquid CDx, Guardant360® Tissue, and Guardant Reveal® tests deliver complete, actionable multiomic insights to guide more informed decisions.†
Therapy response insight
HLA genotyping
Help inform clinical trial enrollment and inform therapy decisions for select indications8-11



Therapy response insight
Methylation-based tumor fraction (%)
Measures circulating tumor DNA (ctDNA) to accurately quantify disease burden.13



Therapy response insight
HRD status
Determine HRD status to inform the use of PARP inhibitors and platinum-based chemotherapies8,12



Enhanced patient identification
Pharmacogenomics
Optimize treatment and reduce toxicity by identifying alleles in CYP2D6, DPYD, UGT1A1, HLA-B, and TPMT8,9



Enhanced patient identification
Likelihood of no FDA-approved actionable biomarkers
Confirm the absence of FDA-approved genomic biomarkers in lung and colorectal cancers for ctDNA results to shorten time to treatment8,14



Enhanced patient identification
Viral status
Detect EBV and HPV to assess prognosis, predict response, and distinguish cancer type8,15,16



Molecular tumor type
Molecular tumor typing
Utilize epigenomic signatures to help identify tissue of origin8,17,18



Molecular tumor type
Lung subtyping
Assess for the presence of adenocarcinoma, squamous cell carcinoma, and small cell lung carcinoma subtypes to complement tissue histologic assessment8,19



Molecular tumor type
Breast subtyping
Assess for the presence of HR, HER2, and TNBC subtypes to complement tissue histologic assessment8,20



| CATEGORY | FEATURE | INTENDED USE | INCLUDED WITH | ||
|---|---|---|---|---|---|
![]() | ![]() | ![]() | |||
| Therapy response insight | HLA genotyping | Help inform clinical trial enrollment and inform therapy decisions for select indications8-11 | |||
| HRD status | Determine HRD status to inform the use of PARP inhibitors and platinum-based chemotherapies8,12 | ||||
| Methylation-based tumor fraction (%) | Measures circulating tumor DNA (ctDNA) to accurately quantify disease burden.13 | ||||
| CATEGORY | FEATURE | INTENDED USE | INCLUDED WITH | ||
|---|---|---|---|---|---|
![]() | ![]() | ![]() | |||
| Enhanced patient identification | Pharmacogenomics | Optimize treatment and reduce toxicity by identifying alleles in CYP2D6, DPYD, UGT1A1, HLA-B, and TPMT8,9 | |||
| Likelihood of no FDA-approved actionable biomarkers | Confirm the absence of FDA- approved genomic biomarkers in lung and colorectal cancers for ctDNA results to shorten time to treatment8,14 | ||||
| Viral status | Detect EBV and HPV to assess prognosis, predict response, and distinguish cancer type8,15,16 | ||||
| CATEGORY | FEATURE | INTENDED USE | INCLUDED WITH | ||
|---|---|---|---|---|---|
![]() | ![]() | ![]() | |||
| Molecular tumor type | Molecular tumor typing | Utilize epigenomic signatures to help identify tissue of origin8,17,18 | |||
| Lung subtyping | Assess for the presence of adenocarcinoma, squamous cell carcinoma, and small cell lung carcinoma subtypes to complement tissue histologic assessment8,19 | ||||
| Breast subtyping | Assess for the presence of HR, HER2, and TNBC subtypes to complement tissue histologic assessment8,20 | ||||
Guardant offers a portfolio of revolutionary liquid and tissue tests—powered by InfinityAI—all with the convenience of a single testing partner
The #1 liquid biopsy†21
The most advanced multiomic tissue test‡
Monitor cancer across the care continuum
View our portfolio of tests, powered by InfinityAI
See the evidence backing Guardant testsAI, artificial intelligence; ctDNA, circulating tumor DNA; EBV, Epstein-Barr virus; HLA, human leukocyte antigen; HRD, homologous recombination deficiency; HPV, human papillomavirus; ML, machine learning; PARP, poly-ADP ribose polymerase
*The only real-world database to include NGS epigenomic results for >400,000 patients
†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.
‡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.
§When compared to other tissue-free testing companies. Comparisons are based on publicly available information as of April 2026.
Important note: Guardant Reveal® and Guardant360® Tissue were developed as Laboratory Developed Tests (LDTs), 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.
References: 1. Guardant Health data on file. October 19, 2023. Guardant Health, Inc. Redwood City, CA. 2. Hanahan D. Hallmarks of cancer: new dimensions. Cancer Discov. 2022;12(1):31-46. doi:10.1158/2159-8290.CD-21-1059 3. Muthamilselvan S, Raghavendran A, Palaniappan A. Stage-differentiated ensemble modeling of DNA methylation landscapes uncovers salient biomarkers and prognostic signatures in colorectal cancer progression. PLoS One. 2022;17(2):e0249151. doi:10.1371/journal.pone.0249151 4. Tomczak K, Czerwińska P, Wiznerowicz M. The Cancer Genome Atlas (TCGA): an immeasurable source of knowledge. Contemp Oncol (Pozn). 2015;19(1A):A68-A77. doi:10.5114/wo.2014.47136 5. Draht MXG, Goudkade D, Koch A, et al. Prognostic DNA methylation markers for sporadic colorectal cancer: a systematic review. Clin Epigenetics. 2018;10:35. doi:10.1186/s13148-018-0461-8 6. Al Aboud NM, Tupper C, Jialal I. Genetics, epigenetic mechanism. In: StatPearls. StatPearls Publishing; 2023. 7. Chakravarthi BV, Nepal S, Varambally S. Genomic and epigenomic alterations in cancer. Am J Pathol. 2016;186(7):1724-1735. doi:10.1016/j.ajpath.2016.02.023 8. Nogueiras-Alvarez 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 9. US Food and Drug Administration. Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. Accessed March 30, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine 10. Gormally MV, Chen MF, Noronha AM, et al. Next-generation sequencing for HLA genotype screening and matching to HLA-restricted therapies. JAMA Oncol. 2025;11(1):74-76. doi:10.1001/jamaoncol.2024.5364 11. Seth R, Messersmith H, Funchain P, et al. Systemic therapy for melanoma: ASCO guideline rapid recommendation update. J Clin Oncol. 2022;40(21):2375-2377. doi:10.1200/JCO.22.00944 12. Safabakhsh P, Tolkunov D, Overstreet B, et al. HRD status prediction using a liquid biopsy assay in advanced solid tumors. J Clin Oncol. 2025;43(16 suppl):3074. doi:10.1200/JCO.2025.43.16_suppl.3074 13. Gross A, Zhao J, Quinn K, et al. Landscape of epigenomic tumor fraction in a large pan-cancer cfDNA cohort. Abstract 5936. Cancer Res. 2025;85(8 suppl 2):5936. doi:10.1158/1538-7445.AM2025-5936 14. Gross AM, Quinn K, Bucheit L, et al. Development and characterization of a negative prediction algorithm for actionable mutations utilizing genomic and epigenomic profiling in cfDNA. Abstract 733. Cancer Res. 2025;85(8 suppl 1):733. doi:10.1158/1538-7445.AM2025-733 15. Huang Y, Wang J, Yang W, et al. Precision therapeutic targets for HPV-positive cancers: an overview and new insights. Infect Agents Cancer. 2025;20(1):17. doi:10.1186/s13027-025-00641-7 16. Yu JW, Wei XJ, Ren G, et al. Association of plasma Epstein-Barr virus DNA with outcomes for patients with recurrent or metastatic nasopharyngeal carcinoma receiving anti-programmed cell death 1 immunotherapy. JAMA Netw Open. 2022;5(3):e220587. doi:10.1001/jamanetworkopen.2022.0587 17. 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 18. Forouzmand E, He Y, Greenwald WW, et al. Epigenomic-based classifier for cancer signal of origin in liquid biopsy for cancer of unknown primary. J Clin Oncol. 2025;43(16 suppl):3073. doi:10.1200/JCO.2025.43.16_suppl.3073 19. Valouev A, Tian W, Singh K, et al. Non-invasive cell-free DNA (cfDNA) methylation profiling for accurate proportional quantification of lung cancer subtypes. Abstract 1142. Cancer Res. 2025;85(8 suppl 1):1142. doi:10.1158/1538-7445.AM2025-1142 20. Tolkunov D, Weipert C, Wienke S, et al. Liquid-based methylation profiling for quantification of breast cancer subtypes. Abstract 3247. Cancer Res. 2025;85(8 suppl 1):3247. doi:10.1158/1538-7445.AM2025-3247 21. Guardant Health data on file. Late-stage Chart Audit. April 2026.


