Urteste plans to start clinical trials for its pancreatic cancer test in Europe in Q3 2025

Core Viewpoint - Urteste S.A. plans to initiate clinical trials for its pancreatic cancer diagnostic test, Panuri, in Europe in Q3 2025, with a focus on obtaining certification and advancing towards commercialization [1][3]. Group 1: Clinical Trials and Regulatory Process - The clinical trials for the Panuri test will involve 550 patients and will be conducted in Poland and selected EU countries [2]. - Urteste is preparing the trial protocol in collaboration with Avania and will announce a tender for a Contract Research Organization (CRO) in Q2 2025 [2]. - The company will hold its fourth Q-submission meeting with the FDA in mid-2025 to finalize details for U.S. trials, with previous meetings yielding positive insights into regulatory expectations [3]. Group 2: Technology and Product Development - Urteste's technology detects cancer through enzyme activity measurement in urine samples, which can indicate the presence of cancer by changing urine color intensity [5][6]. - The company has developed 12 prototype diagnostic tests for various cancers, which account for nearly 70% of global cancer-related deaths [4]. - By mid-2025, Urteste will complete the internal validation of the Panuri test, which will be utilized in both European and U.S. clinical trials [4].