Leading Italian Hospital System To Offer Proprietary Guardant360^® CDx Liquid Biopsy Testing for Therapy Selection in Advanced Cancer Patients

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a partnership with the Agostino Gemelli University Polyclinic Foundation IRCCS (“Policlinico Gemelli”) to establish an in-house liquid biopsy testing service as a part of its diagnostics services within its hospital system. Leveraging Guardant Health’s cutting-edge proprietary digital sequencing platform, this initiative will include on-site analysis of Guardant360^® CDx liquid biopsy tests directly within the Policlinico Gemelli facilities in Rome, Italy.

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The partnership will serve clinical research and patient care needs, marking a significant milestone as one of the first dedicated liquid biopsy testing facilities in Italy housed within a hospital system. This collaboration underscores Guardant Health’s commitment to expanding access to innovative cancer diagnostics and improving patient outcomes globally. Policlinico Gemelli, one of Italy’s largest and most renowned hospitals, serves thousands of cancer patients each year at its comprehensive cancer center. The facility is known for its advanced oncology services, including diagnostics, treatment, and research.

“Gemelli, one of the most important Italian and European oncology centers, can now offer its patients more state-of-the-art diagnostics for precision oncology through this innovative test. This partnership with Guardant Health represents a fundamental step for our hospital,” said Professor Giovanni Scambia, Scientific Director of Policlinico Gemelli.

In Italy, approximately 400,000 new malignant tumor cases are recorded annually. The average of annual deaths caused by tumors, according to the Italian Cancer Registers, is about 3.5 deaths and about 2.5 per 1,000 men and women, respectively, for a total of about three deaths every 1,000 people.¹ Guardant Health’s tests are used by oncologists worldwide to guide treatment decisions across solid tumor cancers and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development.

In 2024, Guardant Health announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

“We’re thrilled to partner with Policlinico Gemelli, empowering clinicians to swiftly detect tumor alterations with a blood test, guiding personalized treatments, and fueling research innovation. This collaboration brings us closer to our mission of ensuring all cancer patients worldwide have access to the latest advancements for optimal care,” said Helmy Eltoukhy, Guardant Health Co-CEO.

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 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 helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About Policlinico Gemelli

Policlinico Universitario Agostino Gemelli IRCCS was founded in July 1964 by the will of Istituto Toniolo di Studi Superiori e Università Cattolica del Sacro Cuore. Home to the Faculty of Medicine and Surgery, it is one of the largest non-state hospitals in Europe and a place where teaching, innovative research, care and assistance activities dialogue. Since August 2015, it has assumed the legal form of a Foundation and, since 2018, the qualification of a Scientific Institute for Hospitalization and Care (IRCCS) for the disciplines of Personalised Medicine and Innovative Biotechnology. Today, Gemelli is also the largest oncology hospital in Italy, with over 50,000 patients treated on average every year, and one of the most important research and assistance centers in Europe. In June 2021, Policlinico Gemelli obtained the accreditation of the Joint Commission International (JCI), one of the largest and most prestigious certification bodies in the world, confirmed for another three years. Furthermore, Gemelli is the best hospital in Italy and 35th in the world according to the World’s Best Hospital 2024 ranking by "Newsweek," in collaboration with Statista Inc.

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, 2023, and any current and periodic 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. Tonetti, C., Tonetti, C., Lombardo, F., Rizzo, F., & Lolli, S. (2022). A review of hospital-based cancer registries in Italy. Scientific Data. https://www.nature.com/articles/s41597-022-01729-0

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