Urteste Expands Development of Innovative Diagnostic Projects

               Urteste Expands Development of Innovative Diagnostic Projects

Gdańsk, Poland – 26 SEPTEMBER 2024, 16:00 CET - Urteste S.A. (Warsaw Stock Exchange: URT),  a biotechnology company specializing in the development of breakthrough technology to detect cancer from urine samples, best known for its flagship project PANURI, a diagnostic test for pancreatic cancer. The company's breakthrough technology allows for early detection of cancer by measuring the activity of enzymes present in urine using proprietary synthetic peptides. One urine sample can be used to screen for many types of cancers. Urteste technology is non-invasive, low-cost to produce, and has high sensitivity and specificity, with results available in up to 2 hours. The diagnostic process is automated to minimize the likelihood of human error.

A proof-of-concept study of 322 participants confirmed the high sensitivity (95.6%) and specificity (95.5%) of the PANURI test. Urteste is currently participating in the FDA Q-Submission program and is seeking an experienced CRO to support a clinical trial in the US.

In addition, Urteste will start the development of a breast cancer diagnostic test project called NASTRO. The Polish Agency for Enterprise Development has just granted the company an approximately $3 million non-refundable grant, which will support clinical trials and move the project significantly closer to the commercialization stage.

Breast cancer is the second most common cancer in the world. According to the “Global Cancer Statistics 2022” report, in 2022 there were more than 2.3 million new cases of breast cancer worldwide and nearly 0.7 million deaths due to these cancers.

“The grant awarded will enable us to develop the NASTRO project independently. We have separated this project from MULTI-CANCER, in which we have a total of 12 oncology diagnostic tests. We see great potential in the NASTRO project. Breast cancers are very common. Their diagnosis at an early stage is still a major challenge. There is a lack of a non-invasive, and yet accurate, method of early diagnosis. We plan to conduct a relatively short, uncomplicated, and relatively inexpensive clinical trial in Europe. Our other projects will focus more on the US market,” said Grzegorz Stefański, CEO and co-founder of Urteste S.A. “However, our priorities remain unchanged. We continue to focus most of our attention on the PANURI project, a test for pancreatic cancer. We plan to have another meeting with the FDA under the Q-Submission program. We are also currently looking for an experienced CRO to support us in conducting a clinical trial in the US,"Stefański added.

In the MULTI-CANCER project, Urteste is developing a diverse portfolio of tests. Urteste now has a pipeline of 12 prototype diagnostic tests for the following cancers: pancreatic, brain, breast, stomach, bile ducts, ovary, endometrial, kidney, colorectal, lung, liver, and prostate, which collectively account for nearly 70% of all cancer deaths worldwide.

Urteste holds Polish patents and international patent applications for its technology. Urteste's patent strategy is to seek patent protection in countries that collectively generate around 90% of global GDP.

The Urteste Management Board will attend MEDICA in Düsseldorf (Germany), 11-14 November.

Urteste (Warsaw Stock Exchange: URT) specializes in developing breakthrough technology to detect cancer at early stages. Urteste's motto is "Early cancer detection saves lives." The company's technology detects cancer by measuring the activity of enzymes present in urine. Urteste is developing tests for a dozen of the most common cancers. The Company's team consists of managers with extensive experience in managing medical companies and scientists specialized in the areas of proteolytic enzymes and peptide chemistry.

For more information please visit www.urteste.eu/en/home/

For further information please contact:

Urteste S.A.
Grzegorz Stefański, CEO [email protected]

Investor and Media Relations
Kamil Majcher [email protected]

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