Bladder cancer is a prevalent malignancy with high morbidity and mortality, particularly when diagnosed at an advanced stage. Early detection is critical, as it significantly improves prognosis and the patient’s outcomes. Bladder cancer also has a high recurrence rate, necessitating long-term surveillance. While cystoscopy remains the gold standard for diagnosis and monitoring, it is invasive and costly. Urine cytology, though widely used, has high specificity for detecting high-grade urothelial carcinoma but suffers from low sensitivity and limited effectiveness as a stand-alone diagnostic tool. Urinary biomarkers offer a promising, noninvasive alternative for early detection and disease surveillance. This review examines FDA-approved urinary biomarker tests, including NMP 22, UroVysion, and BTA, highlighting their clinical utility and limitations. Additionally, we explore emerging biomarkers such as DNA methylation assays, genomic alterations, and proteomic signatures as well as advanced technologies like next-generation sequencing and machine learning-based platforms. These innovations have the potential to enhance diagnostic accuracy, risk stratification, and recurrent monitoring, ultimately improving early detection and long-term disease management. By evaluating both established and emerging urinary biomarkers, this review aims to provide clinicians and researchers with insights into evolving tools for bladder cancer diagnosis and surveillance.
膀胱癌是一种高发病率与死亡率的常见恶性肿瘤,尤其在晚期诊断时预后较差。早期检测至关重要,能显著改善患者预后及治疗效果。该疾病复发率高,需进行长期监测。虽然膀胱镜检查仍是诊断与监测的金标准,但其具有侵入性且费用高昂。尿液细胞学检查虽广泛应用,对高级别尿路上皮癌具有高特异性,但敏感性较低,作为独立诊断工具效果有限。尿液生物标志物为早期检测和疾病监测提供了一种前景广阔的无创替代方案。本综述探讨了美国食品药品监督管理局批准的尿液生物标志物检测方法,包括NMP22、UroVysion和BTA,重点分析其临床应用价值与局限性。此外,我们还研究了新兴生物标志物,如DNA甲基化检测、基因组改变和蛋白质组特征,以及新一代测序和基于机器学习的平台等先进技术。这些创新技术有望提升诊断准确性、风险分层和复发监测能力,最终改善早期检测和长期疾病管理。通过评估现有及新兴尿液生物标志物,本综述旨在为临床医生和研究人员提供膀胱癌诊断与监测领域不断发展的技术工具的深入见解。