- Business
- Urteste S.A. is a Poland-based biotechnology company specializing in the development of innovative in vitro diagnostic tests aimed at early cancer detection through the measurement of enzymatic activity in urine samples. The company’s core products include diagnostic tests for over a dozen common cancers, including pancreatic, prostate, kidney, colorectal, lung, liver, endometrial, ovarian, bile duct, stomach, breast, brain, esophageal cancers, as well as non-Hodgkin lymphoma and leukemia. Urteste’s flagship project, the PANURI test, focuses on pancreatic cancer detection with proven high sensitivity (95.6%) and specificity (95.5%), supported by clinical validation studies. The company’s technology employs proprietary synthetic peptides to identify cancer-related enzymatic activity, offering a rapid, non-invasive, and cost-effective diagnostic solution with results available in approximately two hours.
Founded in 2019 and headquartered in Gdansk, Poland, Urteste operates primarily in the biotechnology and healthcare sectors and is publicly listed on the Warsaw Stock Exchange (WSE: URT). The company targets healthcare providers, clinical laboratories, and research institutions across Europe and plans to expand into the U.S. market, as reflected by its ongoing participation in the FDA Q-Submission program for regulatory approval and clinical trials. Urteste’s recent strategic developments include a tripartite clinical study agreement with Aurevia Poland and Aurevia Oy to organize and manage a European multicenter clinical study of the PANURI test. The company also received an approximately $3 million non-refundable grant from the Polish Agency for Enterprise Development to advance clinical trials for the NASTRO project, a new diagnostic test for early-stage breast cancer detection.
In 2025, Urteste expanded its manufacturing capabilities through a strategic partnership with BIOTYPE, based in Dresden, Germany, to produce batches of PANURI and PANURI Control Kits for analytical evaluation and validation processes. The company maintains a strong focus on commercialization after progressing beyond research and development, signaled by launching clinical trials in Europe and seeking contract research organizations (CROs) for U.S. trial support. Urteste’s product pipeline includes 12 cancer diagnostic test prototypes, collectively addressing cancers responsible for nearly 70% of global cancer mortality, confirming its ambition to transform cancer screening and early detection worldwide with innovative, non-invasive urine-based diagnostics.