Urteste wins USPTO patent for urine-based Panuri pancreatic cancer test
Urteste S.A., a Warsaw-listed diagnostics company, has received a US patent from the United States Patent and Trademark Office for the diagnostic marker underpinning its Panuri test, a non-invasive urine-based assay for the detection of pancreatic cancer. The grant adds the United States to a portfolio of existing patent protections that already covers Poland, Japan, Indonesia, Singapore, Russia, and South Korea, with further applications pending in other markets.
Grzegorz Stefański, co-founder and chief executive, said the US patent was "another significant step in building the value of the Panuri project," citing the country's position as the world's largest market for in vitro diagnostics. He added that the company intends to seek protection for additional components of the Panuri test, which would both broaden and extend the duration of its intellectual property coverage.
Clinical trial underway in Europe
The patent news coincides with an early milestone in Panuri's clinical validation. On 10 June, Urteste announced that the first participant had been dosed in a European trial being conducted across Poland, Hungary, and Italy. The study aims to recruit 550 participants across 30 centres and will evaluate the test's sensitivity and specificity as its primary endpoints. The company expects to receive interim analysis results in the fourth quarter of 2026.
Those results are intended to support Urteste's CE marking application under the EU's In Vitro Diagnostic Regulation and may also contribute to a planned, separate clinical study in the United States. Pancreatic cancer presents a particularly challenging diagnostic target: the majority of cases are diagnosed at a late stage, when surgical resection is rarely possible, giving the disease one of the poorest prognoses in oncology.
Market and competitive context
The early-detection diagnostics space has attracted considerable attention and capital in recent years, with liquid biopsy platforms based on circulating tumour DNA attracting the most prominent investment. Urteste's enzyme-activity approach, which measures the activity of proteolytic enzymes in urine and detects a colour-intensity change, is methodologically distinct from cell-free DNA and RNA-based approaches, and positions the company as pursuing a lower-infrastructure, potentially lower-cost route to cancer detection.
The company reports a portfolio of 13 prototype tests spanning cancers of the breast, brain, stomach, bile ducts, ovaries, bladder, endometrium, kidneys, colon, lungs, liver, pancreas, and prostate, which it says together account for nearly 70% of global cancer-related deaths. Urteste describes this as the world's broadest portfolio of urine-based oncological diagnostic prototypes, though the tests remain at prototype stage and none has yet received regulatory clearance. For context, the broader multi-cancer early detection market is crowded, and clinical validation at scale has proved a high bar for several well-funded competitors.
The interim clinical readout expected in late 2026 will be a closely watched milestone. Strong sensitivity and specificity figures for pancreatic cancer detection from a non-invasive urine sample would meaningfully differentiate Panuri and open substantive conversations with potential licensing or commercialisation partners, as Stefański indicated is part of the company's stated strategy.