Urteste S.A.

Urteste S.A. enrolls the first patient in the Panuri test clinical study

Urteste S.A. enrolls the first patient in the Panuri test clinical study

Gdańsk, Poland – 10 June 2026 – Urteste S.A. (Warsaw Stock Exchange: URT), a company developing innovative technology for the detection of cancer based on urine samples, has enrolled the first patient in the clinical study of the Panuri test for the detection of pancreatic cancer. The company expects to receive the results of the interim analysis in the fourth quarter of this year. The study is proceeding according to schedule and within budget.

Panuri is Urteste’s priority project and involves the development of a non-invasive diagnostic test for in vitro use, based on urine sample analysis. The primary objective of the study is to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer, with the primary endpoints including the test’s sensitivity and specificity.

The use of the Panuri test on the first study participant represents a significant step in the project’s implementation and confirms the transition to the active clinical study phase. The start of participant recruitment significantly reduces the risks characteristic of the preparatory and organizational phase of a clinical study, including those related to test production, the launch of study sites, and the initiation of the recruitment process.

- Enrolling the first patient in a clinical study using the Panuri test is an important step toward commercialization for us. We anticipate a smooth recruitment process and expect the first interim analysis results by the end of the year. Obtaining positive results will significantly increase the likelihood of entering into a partnership agreement. “There is very high interest in the Panuri test,” says Grzegorz Stefański, co-founder and CEO of Urteste S.A. “Panuri is being developed as a non-invasive, effective, and affordable tool to support the early detection of pancreatic cancer—one of the most frequently diagnosed at a late stage and with the poorest prognosis,” adds CEO Stefański.

The study is multicenter and is being conducted in Poland, Hungary, and Italy. Ultimately, it will involve 30 centers in these countries.

Urteste collaborates with experienced international partners. The study is being conducted as a CRO by the Finnish group Aurevia, while the German company Biotype is responsible for the production of the test as a CDMO.

In the study, samples from 550 participants will undergo statistical analysis, including 400 in the target arm (patients with symptoms suggestive of pancreatic cancer) and 150 in the enriched arm (patients with a planned histopathological evaluation of the pancreas).

The study results will form part of the documentation used in the certification process for the IVD (in vitro diagnostic) medical device developed by Urteste in Europe. Furthermore, they may potentially supplement the clinical data obtained in a planned study in the U.S.

Development work on the Panuri test, completed in June 2025, provided preliminary data indicating the solution’s diagnostic potential, including a sensitivity of 89%, specificity of 75%, and diagnostic accuracy of 81% in the analyzed study population.
The data obtained has attracted the interest of potential strategic partners.

Urteste currently has 13 prototypes of diagnostic tests for cancers of the breast, brain, stomach, bile ducts, ovaries, bladder, endometrium, kidneys, colon, lungs, liver, pancreas, and prostate, which together account for nearly 70% of all cancer-related deaths worldwide.

The innovative technology developed by Urteste involves detecting cancers by measuring the activity of enzymes present in urine using specific tests that cause a change in urine color intensity, which may indicate the presence of cancer.

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About Urteste:

Urteste specializes in developing innovative technology for the early detection of cancer. Urteste’s motto is: Early cancer detection saves lives. The company’s breakthrough technology involves detecting cancers by measuring the activity of enzymes present in urine. Urteste is developing diagnostic tests for over a dozen of the most common cancers. The company’s team consists of managers with extensive experience in leading companies in the medical industry and scientists specializing in proteolytic enzymes and peptide chemistry.

Media and Investor Contact:

Kamil Majcher

NewTech Comm

k.majcher@newtechcomm.pl