Introduction to Urteste S.A. and the Panuri Test
Urteste S.A., a company dedicated to pioneering technology for the early detection of cancer, has embarked on a notable journey with the launch of a European multicenter clinical study for the Panuri test. This innovative diagnostic tool aims to identify pancreatic cancer through urine samples, which could potentially transform early diagnosis methods in medical technology. The initiative marks a significant step in the company's ongoing efforts to enhance cancer detection.
Collaboration with Leading Partners
The success of this endeavor is bolstered by a tripartite agreement involving Urteste S.A., Aurevia Poland, and Aurevia Oy from Finland. This partnership focuses on the clinical study's organization and management, ensuring a comprehensive approach to the research process. The study will take place across multiple centers, enriching the data collected and solidifying the significance of the Panuri test.
Funding and Financial Support
The financial aspect of this clinical study is noteworthy, with remuneration set at €3,025,040 net, chiefly supported by a grant from the Polish Agency for Enterprise Development (PARP). This funding will aid the rigorous analysis required for the study, laying the groundwork for future advancements in cancer diagnostics.
Objectives and Expected Outcomes
At the core of the study is a clear objective: to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer. The study is focused on determining key parameters such as sensitivity and specificity, vital for understanding the test's diagnostic capabilities. The results will not only guide Urteste S.A. in refining the Panuri test but also play a role in its certification as an in vitro diagnostic (IVD) medical device in Europe.
Interim Analyses and Participant Involvement
This study promises to gather essential feedback through two interim analyses. The first analysis will occur once 50% of participants diagnosed with pancreatic cancer have enrolled, while the second will assess those diagnosed negatively. A robust sample size of 550 participants has been selected for the study, ensuring a comprehensive evaluation of the test's performance.
Comprehensive Study Design
The study design showcases a remarkable approach to participant inclusion, with 400 participants in the target arm—adults displaying symptoms indicative of pancreatic cancer—and 150 in the enriched arm. This strategic division allows for a more nuanced understanding of the Panuri test's effectiveness across differing patient demographics.
Diagnostic Performance of the Panuri Test
Prior testing of the Panuri test has demonstrated impressive diagnostic parameters: with sensitivity at 89%, specificity at 75%, and diagnostic accuracy reaching 81%. These figures not only highlight the potential of the Panuri test in early cancer detection but also underline Urteste's commitment to advancing cancer diagnostics through innovative technology.
Technology Behind the Panuri Test
Urteste's unique approach involves assessing the enzymatic activity in urine samples, a process that can reveal critical insights into the presence of cancer. This non-invasive technique holds the promise of making early cancer detection more accessible and less intimidating for patients.
About Urteste S.A.
Urteste S.A. is not just focused on pancreatic cancer; the company is pioneering diagnostic tests for various cancer types, including breast, brain, stomach, and prostate cancers, accounting for nearly 70% of all cancer fatalities globally. The team's combined expertise in medical management and biochemical research positions Urteste at the leading edge of cancer detection technology, with a mission centered on saving lives through early diagnosis.
Contact Information
If you want to learn more about Urteste's innovative technologies and the Panuri test, consider reaching out to:
Kamil Majcher
NewTech Comm
Email: k.majcher@newtechcomm.pl
Frequently Asked Questions
What is the Panuri test?
The Panuri test is an in vitro diagnostic medical device aimed at detecting pancreatic cancer through urine samples.
Who is conducting the clinical study?
The clinical study is conducted by Urteste S.A. in collaboration with Aurevia Poland and Aurevia Oy.
What are the funding sources for the study?
The study funding is primarily from a grant provided by the Polish Agency for Enterprise Development (PARP).
What are the sample demographics involved in the study?
The study will analyze samples from 550 participants, including those suspected of having pancreatic cancer and others with planned histopathological evaluations.
What are the expected outcomes of the study?
The study aims to establish the efficacy of the Panuri test while contributing to its certification as an IVD medical device in Europe.
