Clinical Experience with URO17(®) in the Diagnosis and Surveillance of Bladder Cancer

Publication Title

J Clin Med

Document Type

Article

Publication Date

11-16-2025

Keywords

URO17®; bladder cancer; cystoscopy; hematuria; keratin 17 (K17); non-muscle-invasive bladder cancer (NMIBC); noninvasive diagnostics; urinary biomarker; urine cytology; urothelial carcinoma.; california; santa monica; psjhc

Abstract

Objective: To describe the clinical use of URO17®, a noninvasive, urine-based immunocytochemistry assay targeting Keratin 17 (K17), as an adjunct to conventional diagnostic methods for urothelial carcinoma. Materials and Methods: These illustrative cases summarize the real-world use of URO17® in diagnostic workflows for patients presenting with hematuria and those undergoing surveillance for non-muscle invasive bladder cancer (NMIBC). Urine samples were processed via standard immunocytochemistry and interpreted alongside cystoscopic, cytological, and radiographic findings. Discussion: URO17® was used as a complementary diagnostic tool to help guide clinical management. Negative results supported deferral of invasive procedures in selected patients, while positive findings prompted further evaluation when standard tests were inconclusive. Conclusions: In the seven illustrative cases presented, URO17® aided clinical decision-making as part of routine diagnostic and surveillance workflows. The test's integration with existing cytology processes supports its potential role as a noninvasive adjunct for evaluating patients with suspected or recurrent urothelial carcinoma.

Area of Special Interest

Cancer

Specialty/Research Institute

Oncology

Specialty/Research Institute

Urology

DOI

10.3390/jcm14228108

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