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

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.

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

“…Twenty-one studies, comprising 7330 patients, were included in the quantitative synthesis. All the studies included in the quantitative synthesis reported on the diagnostic value of UBTs for the detection of recurrence during surveillance: ten studies on Xpert bladder cancer [17][18][19][20][21][22][23][24][25][26], five studies on Bladder EpiCheck [26][27][28][29][30], three on Adxbladder [31][32][33], two on Uromonitor [34,35], and two on Cxbladder Monitor [36,37].…”

“…Two studies provided data on the diagnostic values of the Uromonitor test for the diagnosis of recurrence during NMIBC follow-up [34,35]. The forest plots revealed that the pooled Se, Sp, PPV, and NPV were 0.93 (95% CI 0.79-0.98), 0.79 (95% CI 0.62-0.90), 0.67 (95% CI 0.36-0.89), and 0.96 (95% CI 0.86-0.99), respectively (Fig.…”

Follow-up in non-muscle invasive bladder cancer: facts and future

“…A comparison of the four largest studies with prospective patient inclusion and markers that are currently marketed is given in Table 1 A final new test for detecting NMIBC recurrence was also published this year: the Uromonitor-V2® test (U-monitor, Porto, Portugal), a urine assay based on the detection of hotspot alterations in three different genes (TERT, FGFR3 and KRAS) for detecting disease recurrence [39]. In all, 97 subjects participated in this prospective, single-visit, caseenriched cohort study.…”

Liquid Biopsy Biomarkers in Urine: A Route towards Molecular Diagnosis and Personalized Medicine of Bladder Cancer

“…Recently, a new urine test called Uromonitor-V2 ® (U-monitor, Porto, Portugal) was developed [ 44 ]. This test combines a group of hotspot mutations in three genes (TERT, FGFR3, and KRAS), among the most common genetic alterations in BC by RT qPCR.…”