Guardant Health, Inc. 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 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.
In Italy, approximately 400,000 new malignant tumor cases are recorded annually. 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®? CD x blood test under the European Union's In Vitro Diagnostic Regulation (IVDR 2017/746). The certification fromTUV SUD 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.
