Guardant Health Introduces New Epigenomic Applications Providing Deeper Insights for Treatment Selection with Guardant360® Liquid

The breast cancer application includes patients without an ESR1 mutation whose tumors may benefit from endocrine therapy.

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• Powered by InfinityAI, expanded capabilities bring together genomics and epigenomics to inform therapy selection in breast and lung cancers and identify additional treatment opportunities

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced new applications for Guardant360^® Liquid designed to help oncologists understand how a patient’s cancer may respond to treatment in the absence of traditional biomarkers.

The expanded capabilities include five key advances: Two novel epigenomic predictors identify patients that may benefit from selective estrogen receptor degraders (SERDs) in advanced breast cancer and immune checkpoint inhibitor (ICI) monotherapy in advanced non-small cell lung cancer (NSCLC). Complementing ICI monotherapy selection in NSCLC, Guardant360 Liquid will also include epigenomic identification of patients who are PD-L1 negative without requiring a tissue sample. Additionally, epigenomic features now identify 20-45% of ALK fusions and over 250% more MTAP deletions missed by genomic liquid testing alone. Together, these multimodal offerings aim to address treatment questions that genomic biomarkers alone may leave unanswered.

The applications are powered by InfinityAI, the smart platform behind Guardant’s next-generation cancer tests. As the only platform with genome-wide methylation coverage, Guardant can uncover more signals of tumor biology that may help physicians assess treatment options.

“By bringing genomics, epigenomics and AI together, Guardant is trailblazing a new standard of oncology care,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Our goal is to translate deeper biological insights into practical information that gives physicians greater confidence in treatment decisions and brings us toward the fulfillment of what precision medicine can be.”

The expanded applications address key clinical needs:

• Informing SERD treatment decisions in breast cancer to help identify patients with hormone receptor-positive, HER2-negative breast cancer progressing on first-line therapy whose tumors may benefit from SERD therapy, including those without an ESR1 mutation. The application will provide insight into endocrine therapy sensitivity in a population where mutation testing alone may not identify all who could benefit.
• Assessing immunotherapy response in advanced lung cancer to uncover the likelihood of benefit from ICI monotherapy vs. chemoimmunotherapy in advanced NSCLC by combining epigenomic tumor microenvironment characterization with tumor mutational burden (TMB) and microsatellite instability.
• Identifying additional ALK fusions by methylation to reveal treatable drivers of a patient’s cancer and potentially increase progression-free survival if the appropriate treatment is selected.
• Enabling blood-based assessment of PD-L1 status to help identify patients with NSCLC who may benefit from chemotherapy in addition to immunotherapy.
• Evaluating new targeted approaches regarding MTAP deletion, including the use of PRMT5 and MAT2A inhibitors, to help inform clinical trial enrollment in advanced lung cancer.

By incorporating advanced insights across genomics and epigenomics, Guardant360 Liquid is designed to provide a more complete view of cancer and support increasingly individualized treatment decisions.

The expansion advances Guardant’s strategy of developing new clinical applications from its oncology testing portfolio, translating discoveries into clinically relevant solutions across the cancer care continuum.

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.

Guardant Health 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, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261110842878/en/

Investor Contact:
Zarak Khurshid
investors@guardanthealth.com

Media Contact:
Meaghan Smith
press@guardanthealth.com

Source: Guardant Health, Inc.

Key Terms

selective estrogen receptor degraders medical

Drugs that latch onto estrogen receptors — the protein “antennae” some cells use to receive growth signals — and trigger those receptors to be broken down and removed. Think of them as taking a key out of a lock and destroying it so the door can no longer open. Investors watch these medicines because their success can alter market value through sales potential for hormone-driven diseases, regulatory milestones, trial results, and licensing or partnership outcomes.

immune checkpoint inhibitor medical

An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.

tumor mutational burden medical

Tumor mutational burden is a measure of how many genetic changes a cancer cell carries, often expressed as the number of mutations per length of DNA. Think of it like counting typos in a book: more typos can make the abnormal cells stand out to the immune system, and cancers with higher counts sometimes respond better to certain immunotherapies. For investors, TMB can affect how well drugs perform in trials, the need for companion diagnostic tests, and the commercial potential of cancer therapies.

microsatellite instability medical

Microsatellite instability is a feature of some tumors where short, repeating bits of DNA become error-prone because the cell’s usual “spell-check” for copying DNA is broken; imagine a document with repeated words that suddenly gain many typos. It matters to investors because it serves as a diagnostic marker and a predictor of which patients may respond to certain cancer drugs and tests, influencing drug trial design, approval chances, and demand for companion diagnostics and targeted therapies.