Urteste S.A., a Polish company specializing in early cancer detection through urine analysis, plans to start clinical trials for its pancreatic cancer test, Panuri, in Europe during the third quarter of 2025. The company will select a Contract Research Organization (CRO) through a tender process in Q2 2025 and is also preparing for clinical trials in the United States, having scheduled a final Q-submission meeting with the FDA in mid-2025. The European trials, involving 550 patients across Poland and other EU countries, are being prepared in collaboration with Avania.
This development marks a critical step towards commercialization for Urteste and its promising cancer detection technology. European approval would not only validate the Panuri test but also offer an earlier pathway to market than the US, providing valuable data and potentially generating revenue sooner. The progress with the FDA further demonstrates the robustness of Urteste’s approach, indicating potential for wider market access in the future. This advancement is particularly crucial given the difficulty of early pancreatic cancer diagnosis and the significant unmet need for more effective screening methods.
The European clinical trial is expected to be more streamlined and less expensive than the anticipated US trial. Internal validation of the Panuri test is projected to be complete by mid-2025, enabling its use in both the European and US trials. Urteste is concurrently developing 12 prototype diagnostic tests for various cancers, representing almost 70% of global cancer-related deaths, all based on their innovative urine-based enzyme activity measurement technology.
The initiation of clinical trials signifies a transition from research and development to real-world application for Urteste. Successful trial results could lead to regulatory approval and commercial launch in Europe, paving the way for wider adoption and potentially revolutionizing cancer screening. The concurrent progress with the FDA further solidifies the company’s position as a potential leader in early cancer detection, creating significant potential for future growth and impact on patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
