Guardant Health Launches Guardant360 Tissue, First Tissue Molecular Profiling Test with Comprehensive Multiomic Analysis to Provide a More Complete View of Cancer

• Powered by Guardant Infinity smart liquid biopsy platform, advanced multiomic test evaluates genomic, epigenomic and RNA-based molecular data
• First tissue comprehensive genomic profiling test to offer exome-wide tumor methylation analysis
• Advanced molecular profiling test requires 40% fewer tissue slides than industry norm, allowing researchers and oncologists to test more patients with less precious tissue

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of Guardant360^® Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis—including DNA, RNA, AI-powered PD-L1 and exome-wide methylation data—to provide researchers and cancer care teams with a more comprehensive view of cancer.

Powered by the Guardant Infinity™ smart liquid biopsy platform, the advanced Guardant360 Tissue test enables insights beyond what can typically be found using tests that do not incorporate comprehensive analysis of epigenetics. These insights can apply to important classes of therapeutics, such as PARP-inhibitors and immunotherapies, as well as important new classes of therapies in late-stage development. The test also enables classification and subtyping of each individual tumor at a much higher resolution, potentially enabling a new era of precision oncology research and clinical applications.

In addition, since Guardant360 Tissue is built on the smart liquid biopsy platform, it requires 92% less tissue surface area for analysis than the industry norm. In a real-world assessment, more than 50% of tumor tissue samples from patients failed to meet the surface area requirement – meaning those patients couldn’t qualify for testing.¹ The Guardant360 Tissue test allows biopharmaceutical researchers and healthcare providers to successfully analyze tissue samples with 40% fewer slides and thus test more patients using less precious tissue.

“Guardant360 Tissue establishes a new standard in tissue molecular profiling, enabling a much broader dimension of insights to provide biopharma and oncologists with an unprecedented view of each individual tumor,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “And because it is built on our smart liquid biopsy platform, the test will leverage the countless multiomic applications that are being built around our Guardant360 liquid biopsy ecosystem. We believe this synergy will provide a new level of clinical actionability and improved patient outcomes across our entire product portfolio.”

For biopharmaceutical partners, the Guardant360 Tissue test offers differentiated molecular profiling by its extensive and unique genomic and epigenomic offering. The test analyzes 742 DNA genes and fusions in 367 RNA genes, with the ability to provide exome-wide analysis of the tumor methylome.

Test results are available in less than two weeks. Guardant360 Tissue is covered by Medicare for eligible patients.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

References

1. Tomlins, Scott A et al. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precision Oncology. 2021.

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Source: Guardant Health, Inc.