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

• Main Authors: 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
• Format: Article
• Language: English
• Published: MDPI AG 2020-09-01
• Series: Diagnostics
• Subjects: biomarkers; bladder cancer; cystoscopy; cytology; follow-up; non-muscle-invasive bladder cancer
• Online Access: https://www.mdpi.com/2075-4418/10/10/745

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 (<i>TERT</i>, <i>FGFR3,</i> and <i>KRAS</i>) 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.