Circular cycle

Unlock a More Complete View of Cancer

Guardant Infinity™ is a robust nondestructive DNA methylation technology ushering in a new era for precision oncology.1

Quantify Cancer With Methylation-Based ctDNA Tumor Fraction

Circulating tumor DNA (ctDNA) detection is a valuable tool throughout drug development—providing insight into tumor fraction to predict response to therapy and monitor disease progression.2

However, there are limitations to genomic-only approaches, including:

Low levels of ctDNA may be missed in early-stage cancer2

Background noise, including clonal hematopoiesis, impacts accuracy2

Only a small subset of variants are tracked by current assays3

Tissue-informed testing faces turnaround delays and sample shortages

Detect MRD and Monitor Response

Guardant Infinity offers a novel methylation-based tissue-free approach to ctDNA detection and quantification to deliver more accurate minimal residual disease (MRD) detection and response monitoring.1,4,5,11

FEATURES & SPECIFICATIONS DETAILS
MRD Detection & Response Monitoring ctDNA detected/not detected
Methylation-based tumor fraction %
Sample Requirement 2 tubes of blood

Dramatically Improve Sensitivity in ctDNA Detection

Tissue-free methylation sequencing features a lower limit of detection (LoD) and a signal that can overcome biological noise, including CH variants.6

Genomic-Only vs Methylation-Based Detection of Late-Stage Circulating Tumor Fraction (TF)6-8

Methylation sequencing can detect tumor signal in cancers with as low as 0.001% circulating tumor fraction, enabling identification of tumor signal in 15% to 50% more cancer patients compared with genomic signals alone.6

Discover How Guardant Infinity Improves MRD and Response Monitoring with Methylation Technology

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Guardant Infinity Demonstrated High Sensitivity and Specificity When Detecting MRD

In an early-stage colon cancer study, Guardant Infinity detected MRD post-surgery without requiring upfront tissue.4,9

80%
Sensitivity
98%
Specificity
See the Study

Guardant Infinity Accurately Quantifies ctDNA Levels and Better Stratifies Patients with Improved Prognosis

In a study of advanced solid tumors, Guardant Infinity overcomes CH noise and increases the percentage of patients with quantifiable ctDNA changes by 20%. Guardant Infinity also showed better stratification of patients with improved progression-free survival (PFS) over genomic methods.5

PFS of Molecular Responders and Molecular Non-Responders

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ctDNA Changes Detected by Guardant Infinity Reflected Real-World Outcomes in Patients with NSCLC

In a prospective trial of advanced non-small cell lung cancer (aNSCLC) patients treated with immunotherapy, serial monitoring with Guardant Infinity improved identification of patients likely to progress and showed significant correlation with real-world PFS and overall survival.10

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Let's Talk About Advancing Your Drug Development Program

  1. Guardant Health data on file. April 2024. Guardant Health, Inc. Redwood City, CA.
  2. Kasi PM, Fehringer G, Taniguchi H, et al. Impact of circulating tumor DNA-based detection of molecular residual disease on the conduct and design of clinical trials for solid tumors. JCO Precis Oncol. 2022;6:e2100181. doi:10/1200/PO.21.00181
  3. Hanahan D. Hallmarks of cancer: new dimensions. Cancer Disc. 2022;12(1):31-46. doi:10.1158/2159-8290.CD-21-1059
  4. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Multiomic analysis for minimal residual disease detection: Addressing challenges in stage II–III colon cancer from COSMOS-CRC-01. J Clin Oncol. 2024;42(suppl 3):180. doi:10.1200/JCO.2024.42.3_suppl.180
  5. Rosen E, Schonhoft JD, Silverman IM, et al. Circulating tumor DNA (ctDNA) genomic and epigenomic profiling (Guardant Infinity™) for diagnosis of DNA damage repair (DDR) loss-of-function (LoF) and response monitoring in the TRESR and ATTACC trials. Poster presented at: AACR-NCI-EORTC (ANE) Conference; October 11-15, 2023; Boston, MA. Poster A123.
  6. Young Greenwald WW, He Y, Chen S, et al. Accurate epigenomic estimates of circulating tumor fraction in large-scale clinical data. Cancer Res. 2022;82(suppl 12):3758-3758. doi:10.1158/1538-7445.AM2022-3758
  7. Sausen M, Parpart S, Diaz LA Jr. Circulating tumor DNA moves further into the spotlight. Genome Med. 2014;6(5):35. doi:10.1186/gm552
  8. Zill OA, Banks KC, Fairclough SR, et al. The landscape of actionable genomic alterations in cell-free circulating tumor DNA from 21,807 advanced cancer patients. Clin Cancer Res. 2018;24(15):3528-3538. doi:10.1158/1078-0432.CCR-17-3837
  9. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Multiomic analysis for minimal residual disease detection: Addressing challenges in stage II–III colon cancer from COSMOS CRC-01. Presented at: ASCO Gastrointestinal Cancers Symposium (ASCO GI) 2024; January 18–20, 2024; San Francisco, CA.
  10. Wienke S, Gordon S, Liang S, et al. Quantification of tumor fraction and outcomes association in a real-world non-small cell lung cancer (NSCLC) cohort using a tissue agnostic epigenomic circulating tumor DNA (ctDNA) assay. Poster presented at: American Association for Cancer Research Annual Meeting; April 8, 2024; San Diego, CA.
  11. Guardant Infinity™ Assay Specifications. February 2025. Guardant Health, Inc. Redwood City, CA.