Urteste S.A. Completes Development of Panuri Test – Company Plans to Launch Clinical Study in Q3 2025

Urteste S.A. Completes Development of Panuri Test – Company Plans to Launch Clinical Study in Q3 2025

Gdańsk, Poland - July 21, 2025 - Urteste S.A. (Warsaw Stock Exchange: URT), a company specializing in the development of innovative technology for cancer detection using a unique method of urine sample analysis, has completed the development phase of its Panuri test and reached technological readiness for clinical performance study. The test is designed to detect pancreatic cancer – one of the most difficult cancers to diagnose. Clinical study in Europe are scheduled to begin in the third quarter of 2025.

Urteste has developed all components of the Panuri test, including buffers, reagents, and a positive control. In-process control was conducted, and the pre-analytical phase was optimized, resulting in high-quality reagents with confirmed structure and purity, as well as reproducible test performance. The result-reading process has also been automated. As a result, the Panuri test complies with the IVDR – Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices.

"Over the past several quarters, we have done tremendous work to transform the Panuri test from an academic-level solution into a product ready for use in clinical study in both Europe and the United States. Thanks to these efforts, we now have a test with high sensitivity and specificity, delivering reproducible and statistically significant results. The tests are inexpensive to produce, and the technology itself enables the detection of several types of cancer through a fully automated result-reading process. All of these factors make us well-positioned within global M&A trends. Large companies in molecular and oncology diagnostics, as well as specialized private equity funds, are looking for such solutions. In the coming months, we will be actively engaging with potential strategic partners," said Grzegorz Stefański, CEO and Co-founder of Urteste S.A. "We are very satisfied with the sensitivity and specificity parameters we have achieved, along with the high repeatability of the measurements. This marks a turning point in Urteste’s development - the product is ready for clinical testing, the clinical study design has been aligned with the FDA, and we are launching our first clinical study in Europe in Q3 this year. Together, these milestones signal a successful transition from R&D to clinical validation and position us strongly for further growth," added CEO Stefański.

Taking into account the strict regulatory requirements of the European and U.S. markets, the assumptions for the clinical performance study design were based on completed R&D work and include a sensitivity of 89%, a specificity of 75%, and a diagnostic accuracy of 81%. These in vitro results were obtained using an OD/h-based result interpretation method, with readings generated by the Tecan Infinite reader. Urteste also explored data-driven algorithm to analyze OD/h readings in silico, focusing on the diagnostic relevance of kinetic curve patterns. The resulting insights were used to implement interpretation logic in the reader software, enabling binary classification of reagent responses based on predefined cut-off values.

While the in vitro results serve as the basis for the clinical performance study, preliminary internal validation performed in silico demonstrated even higher diagnostic potential (89% sensitivity, 87% specificity, 88% accuracy). These promising results suggest that the method could significantly enhance the consistency, objectivity, and scalability of result interpretation in future clinical applications.

The R&D phase of in vitro tests was conducted on a statistically representative group of participants. A very high measurement repeatability was confirmed. The coefficient of variation (CV) for the diagnostic device used (Tecan Fluent) was below 1%.

As part of its ongoing efforts to build strategic relationships and present its innovative diagnostic platform to the global medical community, the company will participate in ADLM 2025 (formerly AACC Annual Scientific Meeting & Clinical Lab Expo), taking place July 27–31 in Chicago. The conference is one of the world’s leading events in laboratory medicine and diagnostics. Urteste S.A. will be represented by Grzegorz Stefański, CEO, and Tomasz Kostuch, CFO.

Urteste currently holds 12 prototype diagnostic tests for cancers of the breast, brain, stomach, bile ducts, ovaries, endometrium, kidneys, colon, lungs, liver, pancreas, and prostate – accounting for nearly 70% of all cancer-related deaths worldwide.

Urteste’s innovative technology detects cancer by analyzing enzyme activity in urine through a biochemical reaction that leads to a change in absorbance, which may correlate with the presence of certain types of cancer.

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About Urteste:

Urteste specializes in the development of innovative technology for early-stage cancer detection. The company’s motto is: Early cancer detection saves lives. Urteste’s breakthrough technology is based on measuring the activity of enzymes present in urine. The company is developing diagnostic tests for over a dozen of the most common types of cancer. Urteste’s team consists of experienced executives from the medical sector and scientists specializing in proteolytic enzymes and peptide chemistry.

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