{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T12:01:37Z","timestamp":1777636897105,"version":"3.51.4"},"reference-count":34,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2020,9,24]],"date-time":"2020-09-24T00:00:00Z","timestamp":1600905600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>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\u00ae 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\u00ae\u2019s 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\u00ae 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\u00ae revealed promising properties for the follow-up of patients with NMIBC.<\/jats:p>","DOI":"10.3390\/diagnostics10100745","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T01:39:33Z","timestamp":1600997973000},"page":"745","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":49,"title":["Clinical Validation of a Urine Test (Uromonitor-V2\u00ae) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients"],"prefix":"10.3390","volume":"10","author":[{"given":"Caroline A.","family":"Sieverink","sequence":"first","affiliation":[{"name":"Department of Urology, Radboud University Nijmegen Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands"}]},{"given":"Rui P. M.","family":"Batista","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"},{"name":"U-Monitor Lda, Rua Alfredo Allen, N\u00ba 461 Paranhos, 4200-461 Porto, Portugal"},{"name":"Department of Pathology, Faculdade de Medicina, Universidade do Porto, Alameda Prof. Hern\u00e2ni Monteiro, 4200-319 Porto, Portugal"}]},{"given":"Hugo J. M.","family":"Prazeres","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"},{"name":"U-Monitor Lda, Rua Alfredo Allen, N\u00ba 461 Paranhos, 4200-461 Porto, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0871-1427","authenticated-orcid":false,"given":"Jo\u00e3o","family":"Vinagre","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"},{"name":"U-Monitor Lda, Rua Alfredo Allen, N\u00ba 461 Paranhos, 4200-461 Porto, Portugal"},{"name":"Department of Pathology, Faculdade de Medicina, Universidade do Porto, Alameda Prof. Hern\u00e2ni Monteiro, 4200-319 Porto, Portugal"}]},{"given":"Cristina","family":"Sampaio","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"}]},{"given":"Ricardo R.","family":"Le\u00e3o","sequence":"additional","affiliation":[{"name":"Department of Urology, Hospital de Braga, Sete Fontes\u2014S\u00e3o Victor, 4710-243 Braga, Portugal"},{"name":"Department of Urology, Hospital CUF Coimbra, Rua Camilo Pessanha 1, 3000-600 Coimbra, Portugal"},{"name":"Faculdade de Medicina de Coimbra (FMUC), Rua Larga 2, 3000-370 Coimbra, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8631-8356","authenticated-orcid":false,"given":"Valdemar","family":"M\u00e1ximo","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"},{"name":"Department of Pathology, Faculdade de Medicina, Universidade do Porto, Alameda Prof. Hern\u00e2ni Monteiro, 4200-319 Porto, Portugal"}]},{"given":"J. Alfred","family":"Witjes","sequence":"additional","affiliation":[{"name":"Department of Urology, Radboud University Nijmegen Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9607-6998","authenticated-orcid":false,"given":"Paula","family":"Soares","sequence":"additional","affiliation":[{"name":"i3S-Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, R. Alfredo Allen 208, 4200-135 Porto; Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua J\u00falio Amaral de Carvalho 45, 4200-135 Porto, Portugal"},{"name":"U-Monitor Lda, Rua Alfredo Allen, N\u00ba 461 Paranhos, 4200-461 Porto, Portugal"},{"name":"Department of Pathology, Faculdade de Medicina, Universidade do Porto, Alameda Prof. Hern\u00e2ni Monteiro, 4200-319 Porto, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2020,9,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"394","DOI":"10.3322\/caac.21492","article-title":"Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries","volume":"68","author":"Bray","year":"2018","journal-title":"Cancer J. 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