Advancements in Cancer Detection Technology at Urteste S.A.
Urteste S.A., a pioneer in innovative cancer detection methods, has marked a significant milestone by completing the development phase of its groundbreaking Panuri test. This test employs a unique approach to analyzing urine samples, specifically targeting pancreatic cancer, a notoriously challenging form of cancer to diagnose. With its technological readiness confirmed, the upcoming clinical performance study is set to commence in the near future.
Details of the Panuri Test Development
The company has meticulously developed all essential components of the Panuri test, which includes specific buffers, reagents, and positive controls to ensure accurate results. Rigorous in-process controls have been implemented, optimizing the pre-analytical phase to provide high-quality reagents with assured structure and purity. Notably, Urteste has also automated the result-reading process, ensuring compliance with the IVDR – the Regulation (EU) 2017/746 regarding in vitro diagnostic medical devices.
CEO Grzegorz Stefa?ski's Insights
Grzegorz Stefa?ski, the CEO and co-founder of Urteste S.A., expressed pride in the transitions made from an academic-level solution to a clinically viable product. The Panuri test boasts high sensitivity and specificity, yielding statistically significant outcomes. Its low production cost and automation capabilities make it an attractive solution in the molecular diagnostics market, appealing to large firms in oncology and molecular diagnostics who are exploring mergers and acquisitions.
Upcoming Clinical Study and Regulatory Standards
Taking into account the strict regulatory frameworks in both European and American markets, the design assumptions for the clinical performance study are grounded on comprehensive R&D results. These findings indicate a remarkable sensitivity of 89%, specificity of 75%, and diagnostic accuracy of 81%. Such metrics were derived using the OD/h-based interpretation method, deploying a Tecan Infinite reader for readings.
Exciting Future Prospects
Preliminary validation studies suggest that the Panuri test may exceed initial expectations, showcasing an impressive sensitivity of 89%, specificity at 87%, and accuracy of 88% under validation conditions. These results herald a promising future for improved consistency and objectivity in cancer detection methods.
Strategic Participation and Global Outreach
Urteste is committed to showcasing its innovative diagnostic platform and nurturing strategic relationships within the medical community. The company plans to feature prominently at ADLM 2025, a key event in the laboratory medicine and diagnostics field. Leadership from Urteste, including CEO Stefa?ski and CFO Tomasz Kostuch, will represent the company, reinforcing its ongoing commitment to industry engagement.
A Broader Impact on Cancer Detection
Currently, Urteste holds a portfolio of 12 prototype diagnostic tests targeting various cancers, which accounts for nearly 70% of global cancer-related mortality. The technology harnesses biochemical reactions to analyze enzyme activity in urine, leading to absorbance changes indicative of potential cancer presence. This pioneering approach emphasizes the vital role such innovations play in cancer diagnosis and patient outcomes.
About Urteste S.A.
Urteste S.A. specializes in innovative early-stage cancer detection technologies. Rooted in the belief that early detection saves lives, the company focuses on assessing enzyme activity through urine analysis. With its efficient team, comprised of seasoned executives and scientists proficient in proteolytic enzymes and peptide chemistry, Urteste is actively developing tests for numerous common cancer types.
Contact Information
Media and Investor Contact:
Kamil Majcher
NewTech Comm
k.majcher@newtechcomm.pl
Frequently Asked Questions
What is the Panuri test?
The Panuri test is a novel diagnostic tool developed by Urteste S.A. for the detection of pancreatic cancer using urine sample analysis.
When will the clinical study for the Panuri test commence?
The clinical study for the Panuri test is set to begin in the upcoming months, with significant preparations already underway.
What makes the Panuri test innovative?
The test integrates automated result reading and has shown promising sensitivity and specificity rates, making it a reliable tool for cancer detection.
Who leads Urteste S.A.?
Urteste S.A. is co-founded and led by CEO Grzegorz Stefa?ski, who is actively involved in the company's strategic direction.
Why is Urteste participating in ADLM 2025?
Urteste aims to showcase its innovative diagnostic solutions at ADLM 2025, building connections within the medical community to enhance collaboration and growth.
