Urteste S.A. has completed development of its Panuri test for pancreatic cancer and plans to begin clinical trials in Europe during Q3 2025. The company has finalized all test components, automated the result reading process, and ensured compliance with the European IVDR regulations. The test is designed to address the difficulty in diagnosing pancreatic cancer, making earlier detection and treatment possible.
This development is a critical step toward addressing the unmet need for reliable and accessible early pancreatic cancer detection. Current diagnostic methods often fail to identify the disease until it’s advanced, leading to poorer patient outcomes. A successful clinical trial for Panuri could significantly improve survival rates by enabling earlier intervention. This could also create a major shift in how pancreatic cancer is managed, potentially lessening the burden on healthcare systems by reducing the need for costly late-stage treatments.
The Panuri test boasts high sensitivity (89%) and specificity (75%), leading to 81% diagnostic accuracy based on in vitro testing. Internal validation conducted in silico suggests even higher potential performance, with 89% sensitivity, 87% specificity, and 88% accuracy. These promising results, coupled with the test’s automated reading process and low production costs, position Urteste attractively for partnerships with larger diagnostic companies or private equity firms seeking innovative cancer detection solutions.
The upcoming clinical trials are crucial for validating the test’s performance in a real-world setting. Positive results would pave the way for regulatory approval and commercialization, potentially transforming pancreatic cancer diagnosis and treatment. The company’s presence at ADLM 2025 offers an opportunity to showcase the technology and further engage potential partners, suggesting a proactive strategy for future growth and market penetration.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
