Diagnostics (Sep 2020)

Clinical Validation of a Urine Test (Uromonitor-V2<sup>®</sup>) 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

DOI
https://doi.org/10.3390/diagnostics10100745
Journal volume & issue
Vol. 10, no. 10
p. 745

Abstract

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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.

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