• For the first time, fundamental tumor phenotypes determined by a simple blood test
• Single test now provides molecular tumor typing, subtyping and confirmation of absence of actionable biomarkers to give clinicians critical insights to guide optimal treatment

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced major new features for the Guardant 360^® Liquid test that greatly expand its biomarker identification and cancer subtyping capabilities to help oncologists identify optimal treatment plans. The expanded applications are enabled through the multiomic profiling capabilities of the Guardant Infinity™ smart liquid biopsy platform and its AI learning engine, which analyzes large sets of patient data to identify patterns and refine predictions.

Some of the groundbreaking new applications for the Guardant360 Liquid test will allow healthcare providers to do the following in order to improve patient outcomes:

• Confirm no actionable mutations in lung and colorectal cancers—helping fast-track patients to treatment without extra testing.
• Identify the origin of cancers when the primary site is unknown, guiding better diagnosis and therapy.
• Classify breast ER/PR/HER2 status and lung cancer histology subtypes with high precision by interpreting tumor-specific methylation signatures, enhancing standard testing methods.
• Use pharmacogenomics to identify genetic variations vital for safe and effective use of common anti-cancer therapies, including those with FDA black box labeling.
• Detect human papillomavirus (HPV) and Epstein-Barr (EBV), which influence prognosis and treatment plans in certain cancers.
• Determine Homologous Recombination Deficiency (HRD) status to inform use of specific therapies like PARP inhibitors and platinum-based chemotherapy.
• Use Human Leukocyte Antigen (HLA) genotyping as a biomarker to inform therapy selection and identify clinical trial opportunities.

“For the first time ever, we’re able to reveal vital details about a tumor – including its fundamental phenotype and biological behavior – from just a blood sample,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This gives healthcare providers the insights they need about a patient’s cancer to make smarter treatment decisions, even when they can’t access tumor tissue for analysis. The novel blood-based approach to comprehensive molecular profiling using our Guardant Infinity Smart Liquid Biopsy platform offers immense potential for future applications in cancer and beyond.”

Comprehensive biomarker testing through immunohistochemistry using tumor tissue has been the standard of care in oncology and helps ensure that clinicians don’t miss critical information about a patient’s specific type of cancer. The Guardant360 Liquid test now provides access to this extensive molecular profiling information through the blood by looking at the unique methylation signatures of specific tumor biomarkers.

Guardant liquid biopsy tests have been clinically validated in more than 1,000 publications and research abstracts. Test results for Guardant360 Liquid are available within seven days. For more information, visit the Guardant Health website.

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.

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