You have accessJournal of UrologyBladder Cancer: Detection and Screening I1 Apr 2015PD23-03 A NOVEL URINE CYTOLOGY STAIN FOR THE DETECTION AND MONITORING OF UROTHELIAL CARCINOMA Ofer Yossepowitch, Yoram Mor, Ofer Nativ, Ilan Leibovitch, Ofer Gofrit, Haim Matzkin, Uri Lindner, Ami Sidi, and Michael Cohen Ofer YossepowitchOfer Yossepowitch More articles by this author , Yoram MorYoram Mor More articles by this author , Ofer NativOfer Nativ More articles by this author , Ilan LeibovitchIlan Leibovitch More articles by this author , Ofer GofritOfer Gofrit More articles by this author , Haim MatzkinHaim Matzkin More articles by this author , Uri LindnerUri Lindner More articles by this author , Ami SidiAmi Sidi More articles by this author , and Michael CohenMichael Cohen More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1419AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Zetiq's CellDetect® is a unique platform technology which enables color and morphological discrimination between malignant and benign cells. The technology is capable of detecting neoplastic changes in a variety of in-vitro and in-vivo systems, including multiple transformed cell lines, body fluid-cytology and tissue biopsies. In a recently published open-label study we have shown that this novel staining technology can identify accurately urothelial carcinoma in both histological and cytological specimens. The objective of the current study was to validate the findings in a blinded setting. METHODS This was a blinded study conducted in several tertiary medical centers enrolling patients with history of urothelial carcinoma prior to their scheduled cystoscopic surveillance visit. The final diagnosis was determined by cystoscopy and a subsequent biopsy when indicated. Early morning urine samples were collected and processed to cytospin smears. One slide per patient was stained by CellDetect® and analyzed by two independent cytopathologists who were blinded to the final diagnosis. The performance characteristics of the CellDetect® technology were determined by comparing the staining results to the reference diagnosis. RESULTS A total of 65 urine smears were collected and stained with the CellDetect®. The CellDetect® staining identified correctly 22 of the 25 cancer cases and 27 of the 40 healthy cases, translating into 88% sensitivity and 68% specificity. Importantly, same sensitivity was observed throughout all grades (88% for high grade, 89% for low grade tumors), suggesting that the test can be applicable for early cancer detection. CONCLUSIONS The findings demonstrate the capability of CellDetect® to identify accurately urothelial carcinoma in urine samples, suggesting that this technology can be further developed to provide a non-invaisve alternative to cystoscopic surveillance. Further investigation is warranted to substantiate its role in routine bladder cancer surveillance. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e481 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ofer Yossepowitch More articles by this author Yoram Mor More articles by this author Ofer Nativ More articles by this author Ilan Leibovitch More articles by this author Ofer Gofrit More articles by this author Haim Matzkin More articles by this author Uri Lindner More articles by this author Ami Sidi More articles by this author Michael Cohen More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...