Urteste Launches European Clinical Trial for Urine-Based Pancreatic Cancer Detection Test
Key Insights
Urteste S.A. (search) has initiated a €3 million European multicenter clinical study of the Panuri test (search), a urine-based diagnostic device for pancreatic cancer (search) detection across Poland, Hungary, and Italy.
The trial will recruit 550 participants to evaluate the test's sensitivity and specificity, building on promising development results showing 89% sensitivity and 75% specificity.
Results will support European IVD certification and potentially supplement planned U.S. clinical data, with first interim analysis expected in 2026.
Polish biotechnology company Urteste S.A. (search) has launched a European multicenter clinical study of its Panuri test (search), a urine-based diagnostic device designed for early detection of pancreatic cancer (search). The company has entered into a tripartite agreement with Aurevia Poland (search) and Aurevia Oy (search) for clinical research organization (CRO) services, with the €3,025,040 study largely financed by a grant from the Polish Agency for Enterprise Development (search) (PARP).
Study Design and Objectives
The clinical trial will be conducted across multiple centers in Poland, Hungary, and Italy, with the primary objective of characterizing the effectiveness of the Panuri test (search) in detecting pancreatic cancer (search). The study's primary endpoints focus on sensitivity and specificity in pancreatic cancer detection.
The trial will recruit 550 participants divided into two arms: 400 participants in the target arm consisting of adults with symptoms suggestive of pancreatic cancer (search), and 150 participants in an enriched arm comprising adults with planned procedures involving histopathological evaluation of the pancreas due to suspected pancreatic cancer.
Two interim analyses are planned during the study. The first will occur once 50% of expected participants with positive pancreatic cancer (search) diagnoses have been enrolled, while the second will take place after 50% of those with negative diagnoses have been included.
Promising Development Results
The Panuri test (search) development, completed in June, demonstrated strong diagnostic parameters with sensitivity of 89%, specificity of 75%, and diagnostic accuracy of 81%. These results support the test's potential as a non-invasive diagnostic tool for one of the most challenging cancers to detect early.
"The launch of the Panuri clinical study is a key milestone in the commercialization strategy for our solution," said Grzegorz Stefański, co-founder and CEO of Urteste S.A. (search) "In our opinion, Panuri has real potential to become a non-invasive, effective, and affordable tool supporting the early diagnosis of pancreatic cancer (search)—one of the most late-detected and deadliest cancers."
Regulatory and Commercial Strategy
The study results will form part of the documentation required for IVD (in vitro diagnostic) medical device certification in Europe. Additionally, the data may potentially supplement clinical information from a planned study in the United States, supporting the company's broader regulatory strategy.
Stefański expressed optimism about patient recruitment, citing the company's partnership with experienced CRO Aurevia and several years of experience in collecting urine samples. The company plans to obtain first interim analysis results in 2026.
Technology Platform and Pipeline
Urteste's innovative technology detects cancer (search) by measuring enzyme activity in urine samples using specialized tests that cause color intensity changes, potentially indicating cancer presence. The company currently has 12 prototype diagnostic tests for cancers affecting the breast, brain, stomach, bile ducts, ovary, endometrium, kidney, colon, lung, liver, pancreas, and prostate—collectively accounting for nearly 70% of all cancer deaths worldwide.
The Panuri trial represents one of Aurevia's first major contracts following a restructuring in May that split the company's CRO and external quality assessment units into separate businesses. Manufacturing supplies for the trial will be provided by Dresden-based Biotype GmbH (search) under a €700,000 supply agreement signed in July.