SUMMARY

Founded in 2015 and headquartered in Porto, U-Monitor is a biotechnology company dedicated to developing non-invasive molecular diagnostic tools in oncology. Its flagship product, Uromonitor®, is a CE/IVD-certified urine test that detects molecular biomarkers of non-muscle-invasive bladder cancer (NMIBC), serving as a complement to cystoscopy in the surveillance of previously diagnosed patients. Rooted in scientific expertise from IPATIMUP and clinically validated across more than 1,100 patient samples in national and international centres, U-Monitor offers a precise, patient-friendly, and cost-efficient alternative to conventional follow-up. Since 2025, Uromonitor® has been included in the shortlist of non-invasive kits recommended in the European Association of Urology (EAU) guidelines — already available in more than 15 countries

PROBLEM

Bladder cancer has a recurrence rate of 50 to 70% after surgery, requiring one of the most intensive surveillance protocols in oncology: cystoscopies every 3 months for the first two years, then every 6 months, then annually. Cystoscopy is an invasive, uncomfortable, and costly procedure — estimated at over 160,000 USD per patient per year — placing a significant burden on both patients and healthcare systems. Furthermore, conventional urine cytology, the only available diagnostic complement, has poor sensitivity, limiting its clinical utility. There is therefore an urgent need for non-invasive, accurate, and scalable alternatives that can reduce reliance on cystoscopy without compromising patient safety.

SOLUTION

Uromonitor® is an in vitro diagnostic kit comprising three steps: urine filtration to capture exfoliated bladder cells, DNA extraction and purification, and real-time PCR detection of mutations in the TERT, FGFR3, and KRAS genes — among the most prevalent in bladder cancer. The process is straightforward, requires only a urine sample, and results are processed at a laboratory. A high-confidence negative result can spare patients unnecessary cystoscopies; a positive result guides clinicians towards prioritised endoscopic evaluation.

Clinically, the test demonstrated 80.2% sensitivity, 96.9% specificity, and a negative predictive value of 96.6% in a meta-analysis of 1,190 tests — a level of evidence that, since 2025, has translated into the inclusion of Uromonitor® in the shortlist of non-invasive kits recommended in the European Association of Urology (EAU) guidelines. U-Monitor is also developing Uromonitor-dPCR, a version for the digital PCR platform, which has shown superior performance over both the real-time PCR version and conventional cytology.

The potential impact is substantial: reduced patient discomfort and anxiety, lower urologist workload, and significant healthcare cost savings — with an estimated reduction of around 50% in bladder cancer surveillance costs.