Accelerating
Precision Oncology

From translational research to clinical development to commercialization, we meet your needs at every stage of drug development.

Ensure Your Clinical Development Program Stays Ahead of the Curve

With a dedicated team of functional experts, including clinical development, bioinformatics, regulatory, scientific affairs, and more, we can position your program for success.

Guardant Health is your one-stop shop for:

Accelerated Patient Enrollment

Expedited Study
Evaluation

Real-Time Clinical Trial Matching

Regulatory Submission Expertise

Guardant Health Is an Established Partner and Industry Leader

20+

CDx approvals in the US, Japan, and the EU

180+

Biopharma partnerships

Accelerate Patient Enrollment With Complementary Liquid and Tissue Profiling

Clinical development can slow down or fail because of challenges in patient identification and enrollment. Complementary liquid and tissue profiling can expedite the process and enrich your clinical trial population with circulating tumor DNA (ctDNA)-positive or biomarker-positive patients.1

Patient Accrual Into Interventional Clinical Trials

7x more patients were prospectively screened using Guardant360 in a study comparing trial enrollment using ctDNA genotyping vs tissue tumor sequencing.1

Expedite Study Evaluation With ctDNA Detection

Liquid biopsy can offer early insight into therapy response to investigational drugs. ctDNA decrease or clearance can be used as a biomarker of clinical response and long-term outcomes, accelerating the drug development process.2-5

ctDNA Predicts Response 8 Weeks Earlier, on Average, Than RECIST Criteria2

In a Phase 1 dose escalation study in patients with advanced solid tumors, changes in ctDNA levels correlated with changes in dose.4

See the Study

In a retrospective analysis of 8 clinical trials of patients with advanced non-small cell lung cancer (NSCLC) treated with a tyrosine kinase inhibitor (TKI), non-detection of ctDNA was associated with improved overall survival (OS) and progression-free survival (PFS) over patients with detected levels of ctDNA.5

Explore Study Findings

Match Patients to the Right Clinical Trial in Real Time

Match Patients to the Right Clinical Trial in Real Time

Through our patient referrals offering, we can work with you and our ordering physicians to refer patients with alterations of interest for whom a trial, or newly approved therapies, could be appropriate. Such referrals are made only with physician and patient consent, in a HIPAA-compliant manner.

We leverage the vast reach of our clinical tests to drive awareness of ongoing studies at the point of care and to overcome historical challenges associated with biomarker screening.

Watch How Methylation Technology Can Enhance Your Clinical Trial

Explore the Science

Simplify Your Submissions and Commercial Activities With a Single CDx Partner

A comprehensive liquid biopsy, delivering genomic and epigenomic insights powered by Guardant Infinity.6,9

The enhanced tissue biopsy, covering clinically relevant biomarkers and delivering multiomic insights powered by Guardant Infinity.7,9

Leverage a CDx Partner With Extensive Regulatory and Global Expertise

Our partnerships continue to grow across biomarkers, tumor types, and regulatory bodies. We currently have 21 CDx approvals in the US, Japan, and the EU, with many more in development.

Broad CDx coverage across key tumor types

Non-Small Cell Lung Cancer

Colorectal Cancer

Breast Cancer

Solid Tumors

Approval across a wide range of biomarkers

BRAF V600E

EGFR L858R

EGFR Exon 19 Deletion

EGFR T790M

EGFR Exon 20 Insertion

ESR1

HER2

HER2 Amp

Get in Touch With Us

  1. Nakamura Y, Taniguchi H, Ikeda M, et al. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies. Nat Med. 2020;26(11):1859-1864. doi:10.1038/s41591-020-1063-5
  2. Zhang Q, Luo J, Wu S, et al. Prognostic and predictive impact of circulating tumor DNA in patients with advanced cancers treated with immune checkpoint blockade. Cancer Discov. 2020;10(12):1842-1853. doi:10.1158/2159-8290.CD-20-0047
  3. 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
  4. Rodon J, Yamamoto N, Doi T, et al. Abstract PR006: initial results from first-in-human study of AMG 193, an MTA-cooperative PRMT5 inhibitor, in biomarker-selected solid tumors. Mol Cancer Ther. 2023;22(suppl 12):PR006. doi:10.1158/1535-7163.TARG-23-PR006
  5. Stires H, Zariffa N, Eisele M, et al. Changes in ctDNA levels as an early indicator of outcomes in advanced NSCLC treated with TKI: initial findings from a retrospective aggregate analysis of 8 clinical trials. J Clin Oncol. 2023;41(suppl 16):3030. doi:10.1200/JCO.2023.41.16_suppl.3030
  6. Guardant360® Assay Specifications. May 14, 2024. Guardant Health, Inc. Redwood City, CA.
  7. Guardant360® Tissue Assay Specifications. March 12, 2025. Guardant Health, Inc. Redwood City, CA.
  8. Guardant Health data on file. January 2025. Guardant Health, Inc. Redwood City, CA.
  9. Guardant360® Liquid 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.