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

Caroline A Sieverink, Rui P M Batista, Hugo J M Prazeres, João Vinagre, Cristina Sampaio, Ricardo R Leão, Valdemar Máximo, J Alfred Witjes, Paula Soares, Caroline A Sieverink, Rui P M Batista, Hugo J M Prazeres, João Vinagre, Cristina Sampaio, Ricardo R Leão, Valdemar Máximo, J Alfred Witjes, Paula Soares

Abstract

The costly and burdensome nature of the current follow-up methods in non-muscle-invasive bladder cancer (NMIBC) drives the development of new methods that may alternate with regular cystoscopy and urine cytology. The Uromonitor-V2® is a new urine-based assay in the detection of hotspot mutations in three genes (TERT, FGFR3, and KRAS) for evaluation of disease recurrence. The aim of this study was to investigate the Uromonitor-V2®'s performance in detecting NMIBC recurrence and compare it with urine cytology. From February 2018 to September 2019 patients were enrolled. All subjects underwent a standard-of-care (SOC) cystoscopy, either as part of their follow-up for NMIBC or for a nonmalignant urological pathology. Urine cytology was performed in NMIBC patients. Out of the 105 patients enrolled, 97 were eligible for the study. Twenty patients presented nonmalignant lesions, 29 had a history of NMIBC with disease recurrence, and 49 had a history of NMIBC without recurrence. In NMIBC, the Uromonitor-V2® displayed a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 93.1%, 85.4%, 79.4%, and 95.3%, respectively. Urine cytology was available for 52 patients, and the sensitivity, specificity, PPV, and NPV were 26.3%, 90.9%, 62.5%, and 68.2%, respectively. With its high NPV of 95.3%, the Uromonitor-V2® revealed promising properties for the follow-up of patients with NMIBC.

Keywords: biomarkers; bladder cancer; cystoscopy; cytology; follow-up; non-muscle-invasive bladder cancer; recurrence; urine test.

Conflict of interest statement

Authors R.P.M.B.; J.V.; P.S. and H.J.M.P. are partners of U-Monitor Lda, the company owing the Uromonitor-V2®. Author F.W. is advisor for Nucleix Ltd. All other authors have no conflicts of interest to declare. The funding sponsor of this research, U-Monitor Lda, had a role in the choice of research project; design of the study; in the collection, analyses and interpretation of data, in the writing of the manuscript and in the decision to publish.

Figures

Figure 1
Figure 1
Comparing ROC curves of urine cytology (red) with Uromonitor-V2® (black) for patients with a history of NMIBC.
Figure 2
Figure 2
A visualization of the Uromonitor-V2® study workflow. SOC, standard-of-care; TURBT, transurethral resection of the bladder tumor.

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