Urteste to Launch European Clinical Trials for Novel Pancreatic Cancer Urine Test in Q3 2025
Key Insights
Urteste (search) S.A. will initiate European clinical trials for its Panuri (search) pancreatic cancer (search) diagnostic test in Q3 2025, involving 550 patients across Poland and selected EU countries.
The company plans to hold its fourth and final Q-submission meeting with the FDA in mid-2025 to finalize U.S. clinical trial design, with internal validation of the Panuri (search) test to be completed by mid-2025.
Urteste (search)'s innovative technology measures enzyme activity in urine samples to detect cancer, with 12 prototype tests currently in development targeting cancers that account for nearly 70% of global cancer-related deaths.
Polish biotech company Urteste (search) S.A. announced plans to initiate clinical trials for its innovative pancreatic cancer (search) diagnostic test in the European Union during the third quarter of 2025. The trials will evaluate the Panuri (search) test, which detects cancer through enzyme activity measurement in urine samples.
The European certification study will involve 550 patients across Poland and other selected EU countries. Urteste (search) is currently preparing the trial protocol in collaboration with Avania (search) and will announce a tender in Q2 2025 to select a Contract Research Organization (CRO) to oversee the clinical trials.
"We plan to begin clinical trials for the Panuri (search) test in Europe in Q3 of this year. The study will be simpler, faster, and more cost-effective than the U.S. trial, but its significance will be substantial," said Grzegorz Stefański, CEO and Co-founder of Urteste (search) S.A. "Conducting this trial will enable us to seek certification in Europe. We will also obtain preliminary results sooner, marking a major milestone that brings us closer to commercializing our technology."
Parallel U.S. Regulatory Strategy
While preparing for European trials, Urteste (search) is simultaneously advancing its U.S. regulatory pathway. The company has scheduled its fourth Q-submission meeting with the FDA for mid-2025, which will serve as the final discussion regarding study design before initiating clinical trials in the United States.
"Our three previous meetings with the FDA have been very positive, helping us better understand regulatory expectations, which is crucial for demonstrating the diagnostic value of our test and achieving a smooth registration process in the U.S.," Stefański noted. The remaining issue to be determined is the number of patients required for the U.S. trial.
By mid-2025, Urteste (search) expects to complete the internal validation of the Panuri (search) test, which will be used in both European and U.S. clinical trials.
Novel Urine-Based Cancer Detection Technology
Urteste (search)'s diagnostic platform represents a potentially significant advancement in early cancer detection. The technology measures the activity of specific enzymes present in urine samples, with changes in urine color intensity potentially indicating the presence of cancer.
The simplicity of urine sample collection could offer advantages over more invasive diagnostic procedures, particularly for cancers like pancreatic cancer (search) that are often diagnosed at advanced stages due to vague early symptoms and challenging detection.
Broad Cancer Detection Portfolio
Beyond pancreatic cancer (search), Urteste (search) has developed 12 prototype diagnostic tests targeting various cancer types, including breast, brain, stomach, bile ducts, ovary, endometrium, kidney, colorectal, lung, liver, and prostate cancers. Collectively, these cancers account for approximately 70% of global cancer-related deaths.
The company's focus on early detection aligns with its motto, "Early cancer detection saves lives," addressing a critical need in cancer care where survival rates typically improve significantly with earlier diagnosis.
Market and Clinical Significance
Pancreatic cancer (search) represents a particularly urgent area of diagnostic need. With a five-year survival rate of approximately 10%, it remains one of the deadliest forms of cancer. Early detection methods could dramatically improve patient outcomes by enabling treatment before the disease progresses to advanced stages.
If successful in clinical trials, Urteste (search)'s non-invasive urine test could potentially transform the pancreatic cancer (search) diagnostic landscape, offering a simple screening method that could be implemented more broadly than current diagnostic approaches.
The company, which trades on the Warsaw Stock Exchange under the ticker URT, has assembled a team of managers with extensive experience in medical companies and scientists specialized in proteolytic enzymes (search) and peptide chemistry to advance its diagnostic platform toward commercialization.