Urteste S.A. launches European multicenter clinical study of the Panuri test
Friday, November 07, 2025
On November 7, 2025, Urteste S.A., a Polish company specializing in innovative urine-based cancer diagnostics, has announced the launch of a major European multicenter clinical study focused on its Panuri test — an in vitro diagnostic (IVD) medical device for the detection of pancreatic cancer. Through a tripartite agreement with contract research organization Aurevia Poland and Finland-based Aurevia Oy, the study will encompass multiple clinical centers across Poland, Hungary, and Italy. The collaboration is structured around comprehensive CRO services, including study organization, management, patient recruitment, and clinical data analytics. Funding for Aurevia’s contribution, totaling EUR 3,025,040 net, is secured primarily via a grant from the Polish Agency for Enterprise Development (PARP), underlining significant regional commitment to oncology innovation.
The core objective of this clinical trial is to validate the effectiveness of the Panuri test for detecting pancreatic cancer at early stages — a cancer notorious for late diagnosis and high mortality. Primary endpoints include sensitivity and specificity of the Panuri test, aiming to provide robust data for regulatory certification across the European region. Urteste’s CEO, Grzegorz Stefański, commented on the strategic importance of this step for commercializing the technology, emphasizing strong interest from leading Medtech players and confidence in their operational capacity to execute smooth patient recruitment and data collection. Initial interim results are anticipated in 2026, with subsequent data forming the backbone of documentation submitted for IVD certification within the European regulatory system. These results may also supplement clinical documentation for future studies intended in the United States.
As part of the clinical protocol, two interim analyses will be performed: the first once 50% of the planned positive-diagnosis participants have enrolled, and the second as the same benchmark is met for negative-diagnosis cases. In total, urine samples from 550 adult participants will be processed — 400 in the main target arm (adults with signs of pancreatic cancer) and 150 in an ‘enriched’ arm (adults scheduled for histopathological pancreatic evaluation due to suspected cancer). Panuri’s previous development cycle, completed earlier in June 2025, revealed strong diagnostic metrics: sensitivity at 89%, specificity at 75%, and overall diagnostic accuracy at 81%. These figures frame Panuri as potentially transformative for early detection and timely intervention in pancreatic cancer care pathways.
Urteste’s broader R&D portfolio encompasses 12 diagnostic prototypes covering cancers of major organs — breast, brain, stomach, bile ducts, ovary, endometrium, kidney, colon, lung, liver, pancreas, and prostate. Combined, these targets account for nearly 70% of global cancer-related deaths, underlining the public health impact and commercial relevance of the company’s pipeline. The proprietary technology driving Panuri centers on detecting proteolytic enzyme activity in urine samples, which is indicated by measurable color intensity shifts in the test, serving as a non-invasive and rapid biomarker for multiple cancer types. This approach stands to dramatically streamline early cancer screening across primary care and specialist settings.
Management at Urteste combines substantial medical industry experience with scientific expertise in biochemistry and enzyme chemistry, which has translated into innovation leadership in European early cancer detection. In the competitive landscape of IVD medical devices, Panuri’s progress under this multicenter European clinical trial could drive regulatory momentum, commercial adoption, and strategic partnerships — factors of critical importance for manufacturers, healthcare executives, and research organizations in the European life sciences ecosystem. The trial’s structure, scale, and envisioned impact illustrate a significant step forward in integrating novel diagnostics into European clinical practice, potentially resetting standards for pancreatic cancer screening, diagnosis, and patient outcomes.
Urteste cautions stakeholders that the press release constitutes information only and does not represent investment solicitation, with all data subject to change as trial milestones are met. The company remains robustly committed to updating clinical, regulatory, and commercial stakeholders as new results and operational updates become available, serving the interests of pharma executives, drug manufacturers, clinical researchers, and regulators aligned with innovation in European oncology diagnostics.
