Guardant Health and Policlinico Gemelli Launch In-House Liquid Biopsy Testing Service in Italy

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the successful launch of FPG 360, an in-house liquid biopsy testing service at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Policlinico Gemelli) in Rome, Italy. This partnership is the latest in a series of public-private partnerships Guardant Health has formed with top-tier European academic and research hospitals that embed its groundbreaking technology with existing care pathways to expand access to more cancer patients.

Policlinico Gemelli will offer on-site liquid biopsy testing based on Guardant360® CDx technology. The collaboration expands access to precision oncology diagnostics and supports both routine care and clinical research. FPG 360 is one of the first dedicated liquid biopsy testing facilities in Italy housed within a hospital system. 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.

The launch builds on Guardant Health’s other successful partnerships with Val d’Hebron/VHIO in Barcelona and The Royal Marsden Hospital, London.

“This collaboration of public healthcare and private innovation enables broader access for blood-based cancer profiling and genomic insights,” said Helmy Eltoukhy, Guardant Health Chairman and co-CEO. “Bringing our liquid biopsy technology to one of Europe’s leading cancer centers is another step in our mission to help clinicians worldwide create more personalized treatment plans and improve outcomes.”

“This is a major advancement for Italian cancer patients, who will now benefit from local access to comprehensive genomic profiling (CGP) liquid biopsy testing without the need to ship samples abroad,” said Professor Antonio Gasbarrini, Scientific Director of Policlinico Gemelli IRCCS.

In Italy, approximately 400,000 new malignant tumor cases are recorded annually.¹ On average, tumors cause about three deaths for every 1,000 people in Italy, including around 3.5 per 1,000 men and 2.5 per 1,000 women each year. 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.

Last year, Guardant Health announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification fromTÜV 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.

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.

About Policlinico Gemelli

Policlinico Universitario Agostino Gemelli 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, 2024 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.

References

1. Cazzolla Gatti, R., Di Paola, A., Monaco, A. et al. A ten-year (2009–2018) database of cancer mortality rates in Italy. Sci Data 9, 638 (2022). https://doi.org/10.1038/s41597-022-01729-0

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