Emerging role of urinary biomarkers in bladder cancer diagnosis and prognosis.

Urinary biomarkers for bladder cancer have long promised to be a minimally invasive alternative or adjunct to cystoscopy and cytology for diagnosis, surveillance, prognostication, and therapeutic decision-making. Multiple Food and Drug Administration( FDA)-cleared tests (protein, chromosomal, and cytogenetic) and a growing array of molecular tests (messenger ribonucleic acid (mRNA) panels, mutation/methylation assays, and next-generation sequencing (NGS) panels) are available or in advanced validation. Nonetheless, heterogeneity in study design, variable pre-analytical handling, standardization, and limited prospective utility data and availability have constrained its clinical adoption. This review summarizes the current evidence on FDA-approved and non-FDA urinary biomarkers, compares their analytical and clinical performance, and discusses their roles in diagnosis, prognosis, treatment selection and response, and surveillance. We then outline the limitations, implementation challenges, economic and regulatory considerations, and a prioritized roadmap for future research to accelerate safe translation into routine clinical practice.