Core Points - Urteste S.A. has launched a European multicenter clinical study for the Panuri test, aimed at detecting pancreatic cancer through urine samples [1][2] - The study will take place in Poland, Hungary, and Italy, with a total of 550 participants [1][5] - The Panuri test has shown promising diagnostic parameters, including 89% sensitivity and 75% specificity [6] Company Overview - Urteste S.A. specializes in innovative technology for early cancer detection, focusing on urine-based diagnostic tests [8] - The company has developed 12 prototypes for various cancers, addressing nearly 70% of global cancer deaths [7] - The technology measures enzyme activity in urine, indicating potential cancer presence through color intensity changes [7][8] Study Details - The primary objective of the study is to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer, focusing on sensitivity and specificity [2] - Two interim analyses will be conducted during the study to assess participant enrollment and diagnostic outcomes [5] - The results will contribute to the certification process for the IVD medical device in Europe and may supplement clinical data for a planned US study [4]

Core Insights - Urteste S.A. has completed the development of its Panuri test for pancreatic cancer detection and plans to initiate clinical studies in Europe in Q3 2025 [1][3] - The Panuri test has achieved high sensitivity (89%) and specificity (75%), with a diagnostic accuracy of 81% based on in vitro results [4] - The company is well-positioned for potential mergers and acquisitions, as large firms in molecular and oncology diagnostics are seeking innovative solutions [3] Company Development - All components of the Panuri test, including buffers, reagents, and controls, have been developed, and the test complies with the IVDR regulations [2] - The test's result-reading process has been automated, enhancing reproducibility and statistical significance [3] - Preliminary internal validation showed even higher diagnostic potential with 89% sensitivity, 87% specificity, and 88% accuracy [5] Market Engagement - Urteste will participate in the ADLM 2025 conference to showcase its diagnostic platform to the global medical community [7] - The company currently holds 12 prototype diagnostic tests for various cancers, addressing nearly 70% of cancer-related deaths worldwide [8] Technology and Methodology - The technology analyzes enzyme activity in urine, correlating changes in absorbance with the presence of certain cancers [8] - The R&D phase involved a statistically representative group, confirming high measurement repeatability with a coefficient of variation below 1% [6]