Urteste S.A. Completes Development of Panuri Test
Urteste S.A. (Warsaw Stock Exchange: URT), a pioneer in innovative cancer detection technology, proudly announces the completion of the development phase for its groundbreaking Panuri test. This test specifically targets pancreatic cancer, a particularly challenging cancer to diagnose effectively. With the company now prepared for clinical performance studies, the stage is set for significant advancements in early cancer detection techniques.
Importance of the Panuri Test for Cancer Detection
The Panuri test features a sophisticated methodology for analyzing urine samples, harnessing a cutting-edge approach that significantly differentiates it from traditional diagnostic techniques. Urteste has meticulously developed all necessary components for this test, which include highly purified reagents and optimized processes that ensure repeatability and accuracy in results. By automating the result-reading process, the Panuri test adheres to the stringent guidelines outlined in the IVDR – Regulation (EU) 2017/746.
CEO Insights on the Development Journey
Grzegorz Stefa?ski, the CEO and Co-founder of Urteste, expressed immense pride in the journey taken to transition from an academic-level solution to a clinically tested product. He stated, "Our efforts have led to a test boasting remarkable sensitivity and specificity, with the potential to detect several cancer types reliably. Such progress places us at the forefront of the market, enabling us to attract attention from major players in oncology diagnostics and private equity sectors."
Successful Alignment with Regulatory Standards
As Urteste prepares for clinical studies in Europe, the design takes into account all requisite regulatory requirements. With a sensitivity of 89%, specificity of 75%, and an overall diagnostic accuracy of 81%, the test promises to provide immense value in clinical settings. The data interpretation method utilized was based on an optical density/h-based result interpretation, showcasing the efficiency of the Tecan Infinite reader in data analysis.
Enhancing Diagnostic Accuracy
Interestingly, internal validation efforts indicate even more promising outcomes. Preliminary insights suggest extraordinary potential with sensitivity at 89%, specificity at 87%, and overall accuracy at 88%. Such improvements indicate a bright future for the Panuri test and its application in clinical diagnostics.
Strategic Efforts and Future Participation
To further bolster its commitment to showcasing innovative diagnostic solutions, Urteste plans to participate in ADLM 2025. This premier event taking place in Chicago will gather influential voices in laboratory medicine, creating invaluable networking opportunities for the company. Representing Urteste at the conference will be CEO Grzegorz Stefa?ski and CFO Tomasz Kostuch, ready to engage with the global community about their advancements.
Continuous Development in Cancer Testing Technologies
With an impressive portfolio of 12 prototype diagnostic tests targeting various cancers, including those of the breast, brain, and pancreas, Urteste addresses approximately 70% of global cancer-related mortality. The company’s unique technology not only analyzes enzyme activity in urine but also translates biochemical changes into potential early detection indicators for cancer.
About Urteste
Founded with a resolute focus on early cancer detection, Urteste’s philosophy emphasizes that early intervention saves lives. By developing reliable tests that utilize enzyme activity measured through urine analysis, Urteste stands out in the diagnostics field. The team combines the expertise of seasoned medical professionals and scientists dedicated to advancing cancer research and diagnostics.
Frequently Asked Questions
What is the Panuri test developed by Urteste S.A.?
The Panuri test is an innovative method for detecting pancreatic cancer through urine analysis, showcasing enhanced sensitivity and specificity.
When is the clinical study for the Panuri test expected to begin?
The clinical studies are scheduled to commence in the third quarter of 2025.
What key features characterize the Panuri test?
It features high sensitivity, specificity, an automated result-reading process, and meets the IVDR standards.
Where will Urteste S.A. showcase its advancements?
Urteste will participate in the ADLM 2025 event in Chicago, engaging with the medical community.
How many diagnostic tests does Urteste currently hold?
Urteste currently holds 12 prototype tests for various types of cancer, addressing a significant portion of cancer-related deaths globally.
