Guardant Health and Policlinico Gemelli Announce Partnership to Establish A Dedicated In-House Liquid Biopsy Testing Service in Italy
Guardant Health (Nasdaq: GH) has announced a partnership with Policlinico Gemelli, a leading Italian hospital, to establish an in-house liquid biopsy testing service in Italy. This collaboration will enable on-site analysis of Guardant360® CDx liquid biopsy tests at Policlinico Gemelli's facilities in Rome. The partnership aims to serve both clinical research and patient care needs, marking one of the first dedicated liquid biopsy testing facilities within an Italian hospital system.
Policlinico Gemelli, serving thousands of cancer patients annually, will now offer advanced diagnostics for precision oncology. This initiative aligns with Guardant Health's mission to expand access to innovative cancer diagnostics globally. In 2024, Guardant Health received IVDR certification for its Guardant360® CDx blood test, allowing for tumor mutation profiling and companion diagnostic indications in various solid cancers.
Guardant Health (Nasdaq: GH) ha annunciato una collaborazione con il Policlinico Gemelli, un ospedale italiano di riferimento, per stabilire un servizio di test per biopsia liquida in-house in Italia. Questa collaborazione consentirà l'analisi in loco dei test di biopsia liquida Guardant360® CDx presso le strutture del Policlinico Gemelli a Roma. L'obiettivo del partenariato è soddisfare le esigenze della ricerca clinica e della cura dei pazienti, segnando uno dei primi centri dedicati ai test di biopsia liquida all'interno di un sistema ospedaliero italiano.
Il Policlinico Gemelli, che serve migliaia di pazienti oncologici ogni anno, offrirà ora diagnostiche avanzate per l'oncologia di precisione. Questa iniziativa è in linea con la missione di Guardant Health di espandere l'accesso a diagnosi innovative per il cancro a livello globale. Nel 2024, Guardant Health ha ricevuto la certificazione IVDR per il suo test del sangue Guardant360® CDx, consentendo il profiling delle mutazioni tumorali e indicazioni diagnostiche companion in vari tumori solidi.
Guardant Health (Nasdaq: GH) ha anunciado una asociación con el Policlinico Gemelli, un hospital líder en Italia, para establecer un servicio de pruebas de biopsia líquida interno en Italia. Esta colaboración permitirá el análisis en sitio de las pruebas de biopsia líquida Guardant360® CDx en las instalaciones del Policlinico Gemelli en Roma. La asociación tiene como objetivo satisfacer las necesidades de investigación clínica y atención al paciente, marcando uno de los primeros centros dedicados a las pruebas de biopsia líquida dentro de un sistema hospitalario italiano.
El Policlinico Gemelli, que atiende a miles de pacientes con cáncer anualmente, ahora ofrecerá diagnósticos avanzados para la oncología de precisión. Esta iniciativa se alinea con la misión de Guardant Health de expandir el acceso a diagnósticos innovadores del cáncer a nivel mundial. En 2024, Guardant Health recibió la certificación IVDR para su prueba de sangre Guardant360® CDx, permitiendo el perfilado de mutaciones tumorales e indicaciones diagnósticas complementarias en varios cánceres sólidos.
Guardant Health(NASDAQ: GH)는 이탈리아의 주요 병원인 Policlinico Gemelli와 파트너십을 맺고 이탈리아에서 내부 액체 생검 검사 서비스를 설립한다고 발표했습니다. 이 협력은 Policlinico Gemelli의 로마 시설에서 Guardant360® CDx 액체 생검 검사를 현장에서 분석할 수 있게 해줍니다. 이 파트너십의 목표는 임상 연구 및 환자 치료의 필요를 충족시키는 것으로, 이탈리아 병원 시스템 내에서 전용 액체 생검 검사 시설 중 하나로 자리 잡고 있습니다.
Policlinico Gemelli는 매년 수천 명의 암 환자를 치료하고 있으며, 이제 정밀 종양학을 위한 고급 진단 서비스를 제공합니다. 이 이니셔티브는 전 세계적으로 혁신적인 암 진단에 대한 접근을 늘리려는 Guardant Health의 사명과 일치합니다. 2024년 Guardant Health는 IVDR 인증을 획득하여 Guardant360® CDx 혈액 검사에 대해 종양 변이 프로파일링 및 다양한 고형 암의 동반 진단 기회를 제공합니다.
Guardant Health (Nasdaq: GH) a annoncé un partenariat avec le Policlinico Gemelli, un hôpital italien de premier plan, pour établir un service de test de biopsie liquide en interne en Italie. Cette collaboration permettra l'analyse sur place des tests de biopsie liquide Guardant360® CDx dans les installations du Policlinico Gemelli à Rome. L'objectif de ce partenariat est de répondre aux besoins de la recherche clinique et des soins aux patients, marquant l'une des premières installations de test de biopsie liquide dédiées au sein d'un système hospitalier italien.
Le Policlinico Gemelli, qui sert des milliers de patients atteints de cancer chaque année, proposera désormais des diagnostics avancés pour l'oncologie de précision. Cette initiative s'inscrit dans la mission de Guardant Health d'élargir l'accès à des diagnostics innovants du cancer à l'échelle mondiale. En 2024, Guardant Health a reçu la certification IVDR pour son test sanguin Guardant360® CDx, permettant le profilage des mutations tumorales et des indications diagnostiques accompagnatrices dans divers cancers solides.
Guardant Health (Nasdaq: GH) hat eine Partnerschaft mit dem Policlinico Gemelli, einem führenden italienischen Krankenhaus, angekündigt, um einen interne Flüssigbiopsie-Testdienst in Italien einzurichten. Diese Zusammenarbeit ermöglicht die Vor-Ort-Analyse der Guardant360® CDx Flüssigbiopsietests in den Einrichtungen des Policlinico Gemelli in Rom. Das Ziel der Partnerschaft ist es, sowohl die Bedürfnisse der klinischen Forschung als auch der Patientenversorgung zu erfüllen und zählt zu den ersten speziellen Flüssigbiopsie-Testeinrichtungen innerhalb eines italienischen Gesundheitssystems.
Das Policlinico Gemelli, das jährlich Tausenden von Krebspatienten dient, wird jetzt fortschrittliche Diagnosen für die Präzisionsonkologie anbieten. Diese Initiative steht im Einklang mit der Mission von Guardant Health, den Zugang zu innovativen Krebsdiagnosen weltweit zu erweitern. Im Jahr 2024 erhielt Guardant Health die IVDR-Zertifizierung für seinen Guardant360® CDx Bluttest, die die Tumormutationsprofilierung und begleitende diagnostische Indikationen bei verschiedenen soliden Tumoren ermöglicht.
- Partnership with Policlinico Gemelli expands Guardant Health's presence in the Italian market
- Establishment of an in-house liquid biopsy testing service at a major Italian hospital
- Guardant360® CDx blood test received IVDR certification for use in the European Union
- Potential for increased adoption of Guardant Health's diagnostic services in Italy's large cancer patient population
- None.
This partnership between Guardant Health and Policlinico Gemelli marks a significant advancement in precision oncology for Italy. The establishment of an in-house liquid biopsy testing service using Guardant360® CDx technology will enhance diagnostic capabilities and expedite treatment decisions for cancer patients. This collaboration is particularly impactful considering Italy's high cancer incidence, with approximately 400,000 new cases annually.
The integration of Guardant Health's digital sequencing platform within Policlinico Gemelli's facilities represents a pioneering move in Italian healthcare. It will enable rapid, on-site analysis of tumor mutations, potentially reducing diagnostic turnaround times and improving patient outcomes. This development aligns with the global trend towards personalized medicine in oncology, potentially setting a new standard for cancer care in Italy and beyond.
The introduction of Guardant360® CDx liquid biopsy testing at Policlinico Gemelli is a game-changer for Italian oncology. This non-invasive method allows for real-time monitoring of tumor evolution and treatment response, important for optimizing cancer care. The ability to detect circulating tumor DNA from a simple blood draw can overcome limitations of tissue biopsies, such as tumor heterogeneity and inaccessible tumor locations.
Moreover, this partnership could significantly accelerate clinical research in Italy. By facilitating easier patient enrollment and monitoring in clinical trials, it may lead to faster development of new targeted therapies. The IVDR certification of Guardant360® CDx for multiple cancer types further validates its clinical utility, potentially expanding its application across various solid tumors and enhancing precision medicine practices in Italian oncology.
This partnership represents a strategic move for Guardant Health to expand its footprint in the European market. By establishing a presence in one of Italy's leading hospitals, Guardant Health gains access to a significant patient population and research opportunities. This could lead to increased adoption of their technology across Italy and potentially other European countries.
For Guardant Health investors, this development signals strong growth potential in international markets. The company's ability to secure partnerships with prestigious institutions like Policlinico Gemelli demonstrates the increasing global demand for their liquid biopsy technology. However, it's important to note that the financial impact may take time to materialize, as adoption and integration of new diagnostic technologies can be gradual. Nonetheless, this partnership positions Guardant Health favorably in the competitive and rapidly growing global precision oncology market.
Leading Italian Hospital System To Offer Proprietary Guardant360® CDx Liquid Biopsy Testing for Therapy Selection in Advanced Cancer Patients
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
“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
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
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
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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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Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Guardant Health
Melissa Marasco
press@guardanthealth.com
+1 650-647-3711
Policlinico Gemelli
Nicola Cerbino
nicola.cerbino@policlinicogemelli.it
+ 39 06 3015 4442
Source: Guardant Health, Inc.
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