Testing A Novel Molecular Urine Assay in Patients with Equivocal Urine Cytology - Expert Commentary

Urine cytology plays a critical role as a noninvasive tool in bladder cancer detection and surveillance. However, a substantial fraction of cytology tests is classified as atypical or indeterminate. A need for a minimally-invasive high sensitivity and specificity test that can early detect genetic alterations associated with bladder cancer in these patients is needed.

A recent study published by Rodriguez Pena et al. evaluated the performance of a new urine assay “UroSEEK” in patients with bladder cancer. UroSEEK detects alterations in the TERT gene promoter, FGFR3, TP53, CDKN2A, ERBB2, HRAS, KRAS, PIK3CA, MET, VHL, and MLL genes and aneuploidy. The investigators had two groups of patients: the early detection group and the surveillance group based on their diagnosis status. The early detection group patients presented with upper tract symptoms or hematuria but were not diagnosed with bladder cancer, while the surveillance group included patients with a history of bladder cancer. 

The investigators found that UroSEEK has high sensitivity (96%), high specificity (88%), and a high negative predictive value (99%) in the early detection cohort. Interestingly, in the surveillance group, UroSEEK had a sensitivity of 74%, a specificity of 72%, and a negative predictive value of 53%. Seven cases in the early detection cohort and 71 surveillance cases were detected at least six months before the clinical diagnosis.

The UroSEEK are promising and suggest that molecular techniques can aid urine cytology in the diagnosis and surveillance of bladder cancer patients.

Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine


1. Rodriguez Pena MDC, Springer SU, Taheri D, Li L, Tregnago AC, Eich ML, Eltoum IA, VandenBussche CJ, Papadopoulos N, Kinzler KW, Vogelstein B, Netto GJ. Performance of novel non-invasive urine assay UroSEEK in cohorts of equivocal urine cytology. Virchows Arch. 2019 Sep 3. doi: 10.1007/s00428-019-02654-1.

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