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01-03-2020 | Urothelial Cancer | Original Article

Performance of novel non-invasive urine assay UroSEEK in cohorts of equivocal urine cytology

Authors: Maria Del Carmen Rodriguez Pena, Simeon U. Springer, Diana Taheri, Lu Li, Aline C. Tregnago, Marie-Lisa Eich, Isam-Eldin A. Eltoum, Christopher J. VandenBussche, Nickolas Papadopoulos, Kenneth W. Kinzler, Bert Vogelstein, George J. Netto

Published in: Virchows Archiv | Issue 3/2020

Abstract

Urine cytology is an essential element of the diagnostic work up of hematuria. A significant proportion of cases continue to be placed in the “atypical” or “suspicious” categories of the Paris system for urine cytology, posing difficulty in patient management. We report on the performance of our recently described urine-based assay “UroSEEK” in cases with equivocal diagnosis in patients who are investigated for bladder cancer. Urine samples were collected from two cohorts. The first consisted of patients who presented with hematuria or lower urinary tract symptoms (early detection cohort) and the second of patients that are in follow-up for prior bladder cancer (surveillance cohort). Urine samples were analyzed for mutations in 11 genes and aneuploidy. In the early detection setting, we found high sensitivity and specificity (96% and 88%, respectively) and a strong negative predictive value of 99%. The assay performance was less robust in the surveillance cohort (sensitivity of 74%, specificity of 72%, and negative predictive value of 53%). UroSEEK demonstrated a notable lead time to cancer diagnosis. Seven cases in the early detection cohort and 71 surveillance cases were detected at least 6 months prior to clinical diagnosis. Our results suggest a potential role for UroSEEK assay in guiding management of patients with atypical urine cytology if confirmed in future prospective trials.

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Title: Performance of novel non-invasive urine assay UroSEEK in cohorts of equivocal urine cytology
Authors: Maria Del Carmen Rodriguez Pena
Simeon U. Springer
Diana Taheri
Lu Li
Aline C. Tregnago
Marie-Lisa Eich
Isam-Eldin A. Eltoum
Christopher J. VandenBussche
Nickolas Papadopoulos
Kenneth W. Kinzler
Bert Vogelstein
George J. Netto
Publication date: 01-03-2020
Publisher: Springer Berlin Heidelberg
Keywords: Urothelial Cancer
Urothelial Cancer
Published in: Virchows Archiv / Issue 3/2020
Print ISSN: 0945-6317
Electronic ISSN: 1432-2307
DOI: https://doi.org/10.1007/s00428-019-02654-1

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Performance of novel non-invasive urine assay UroSEEK in cohorts of equivocal urine cytology

Abstract

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Abstract

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