Kravchuk et_al_2024: Urine-Based Biomarker Test Uromonitor®; in the Detection and Disease Monitoring of Non-Muscle-Invasive Bladder Cancer—A Systematic Review and Meta-Analysis of Diagnostic Test Performance

A recent systematic review and meta-analysis evaluated the performance of Uromonitor®, a urine-based biomarker test for non–muscle-invasive bladder cancer (NMIBC). Analyzing 1,190 tests across four studies, Uromonitor® achieved 80.2% sensitivity, 96.9% specificity, and a high negative predictive value (96.6%). Compared to urinary cytology, Uromonitor® significantly improved sensitivity and test accuracy, reducing unnecessary cystoscopies by up to 825 per 1,000 patients. Its DNA-based approach effectively detects key mutations (TERT, FGFR3, KRAS), making it a reliable, non-invasive alternative for NMIBC monitoring. These findings position Uromonitor® as a superior tool for optimizing bladder cancer surveillance.

Ramos_et_al: Uromonitor: Clinical Validation and Performance Assessment of a Urinary Biomarker Within the Surveillance of Patients With Non–Muscle-Invasive Bladder Cancer | Journal of Urology

A recent clinical study evaluated the effectiveness of Uromonitor, an innovative urinary biomarker for the surveillance of non–muscle-invasive bladder cancer (NMIBC). In a cohort of 439 patients with 528 surveillance episodes, Uromonitor demonstrated a sensitivity of 87% and specificity of 99%, along with a negative predictive value of 99%. These results confirm its reliability in the early detection of recurrences, reducing the need for invasive cystoscopies and associated healthcare costs. Uromonitor emerges as a promising solution, offering a non-invasive, effective, and cost-efficient approach to optimizing NMIBC management.

Cancers: Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial

Uromonitor®: Reducing Unnecessary Cystoscopies and TURBT Procedures

Non-muscle-invasive bladder cancer (NMIBC) follow-up relies on frequent cystoscopies, which are invasive, costly, and uncomfortable. Uromonitor® is a non-invasive urine test that detects NMIBC recurrence with high accuracy, significantly reducing unnecessary procedures.

Fewer Cystoscopies – Uromonitor® could have prevented 87.4% of unnecessary cystoscopies, reducing patient discomfort and healthcare costs.

Avoiding Unnecessary Surgeries – The test accurately identified 28 cases where TURBT was performed unnecessarily due to false-positive cystoscopies.

High Diagnostic Accuracy – With 89.7% sensitivity, 96.2% specificity, and a 98.8% negative predictive value (NPV), Uromonitor® offers a reliable alternative for NMIBC surveillance.

By minimizing unnecessary interventions, Uromonitor® enhances patient well-being while optimizing healthcare resources, making NMIBC follow-up more efficient and patient-friendly.

Diagnostics: Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients

Uromonitor-V2®: A Breakthrough in NMIBC Surveillance

Bladder cancer (BCa) requires lifelong monitoring, but traditional methods like cystoscopy and urine cytology are invasive, costly, and often lack sensitivity.

Uromonitor-V2® is a non-invasive urine test that detects TERT, FGFR3, and KRAS mutations using real-time qPCR. Clinically validated, it outperforms urine cytology with 93.1% sensitivity and 85.4% specificity, ensuring high accuracy in detecting NMIBC recurrence. Its negative predictive value (NPV) of 95.3% provides confidence in ruling out recurrence.

With results in just six hours, Uromonitor-V2® offers a faster, more reliable, and cost-effective alternative to traditional surveillance methods.

At Uromonitor, we are committed to improving patient care by providing cutting-edge, accessible diagnostics. Our mission is to revolutionize NMIBC follow-up with a highly sensitive, non-invasive solution.

Biomarkers for bladder cancer diagnosis and surveillance: a comprehensive review

Uromonitor test was recognized and considered by the scientific community as an excellent alternative for the non-invasive follow-up of patients previously diagnosed with Non-Muscle Invasive Bladder Cancer in a scientific article that was issue cover in an recognized international journal (Diagnostics). 

Validation of a novel, sensitive, and specific urine-based test for recurrence surveillance of patients with non-muscle-invasive bladder cancer in a comprehensive multicenter study

The Uromonitor test was recently validated by the scientific community in a international recognized peer-reviewed journal (Frontiers in Genetics) in a multicentric study comprising more than 300 human samples. Uromonitor presented high sensitivity (74%) and specificity (93%) in the detection of recurrence in patients under Follow-up for Non-Muscle Invasive Bladder Cancer.