Mp13-15 Molecular Urine Cytology – Bladder Epicheck Is a Novel Molecular Diagnostic Tool for Monitoring of Bladder Cancer Patients

You have accessJournal of UrologyBladder Cancer: Non-Invasive I1 Apr 2016MP13-15 MOLECULAR URINE CYTOLOGY – BLADDER EPICHECK IS A NOVEL MOLECULAR DIAGNOSTIC TOOL FOR MONITORING OF BLADDER CANCER PATIENTS Adam Wasserstrom, Danny Frumkin, Zohar Dotan, Elena Bukin, Tal Gadish, Shiri Hanuka, Revital Knirsh, Abd Elhalim Darawsha, and Ilan Leibovitch Adam WasserstromAdam Wasserstrom , Danny FrumkinDanny Frumkin , Zohar DotanZohar Dotan , Elena BukinElena Bukin , Tal GadishTal Gadish , Shiri HanukaShiri Hanuka , Revital KnirshRevital Knirsh , Abd Elhalim DarawshaAbd Elhalim Darawsha , and Ilan LeibovitchIlan Leibovitch View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2496AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Bladder EpiCheck is a novel DNA methylation-based assay for detection of bladder cancer (BC) in voided urine samples, based on identification of DNA methylation changes associated with BC in a panel of 15 genomic biomarkers. The assay, which acts as a sort of user-independent "molecular urine cytology", generates a numerical EpiScore (0-100) reflecting the overall methylation level in the urine sample. An EpiScore =60 is considered positive for BC. The aim of this study was to compare the sensitivity and specificity of the assay to that of cytology in a population of patients with history of BC. METHODS Voided urine samples from 222 patients with history of BC undergoing routine surveillance were tested with Bladder EpiCheck. 40/222 patients (18%) had biopsy-proven recurrent BC. (16-Ta, 11-T1, 3-T2, 11-CIS and 2 unspecified) (19-LG, 19-HG, 2 unspecified). Cytology evaluation results were available in 175 of these samples. Statistical analysis was performed using the Kolmogorov-Smirnov test. RESULTS Bladder EpiCheck had overall sensitivity of 90%, correctly diagnosing 36/40 BC cases (sensitivity breakdown: 81%,100%,100%,91%, 84%, 95%; in TA, T1,T2, CIS, LG, HG respectively) and overall specificity of 83%, correctly diagnosing 151/182 cancer-free patients. Negative Predictive Value was 97%. In comparison cytology had 38% sensitivity, correctly diagnosing 5/13 BC cases and 96% specificity, correctly diagnosing 155/162 cancer-free patients. Significantly, Bladder EpiCheck detected all tumors that were detected by cytology, and all of the tumors that were missed by Bladder EpiCheck were also missed by cytology. The average EpiScore was 69 and 85 for patients with LG and HG tumors, respectively, hence significantly correlated with tumor grade (p = 0.006). CONCLUSIONS Bladder EpiCheck is a sensitive and specific operator-independent assay for the detection of BC in voided urine samples. In comparison with cytology, Bladder EpiCheck has significantly higher sensitivity with somewhat lower specificity. Our results suggest that Bladder EpiCheck can be used instead of urine cytology in monitoring of BC patients without the risk of missing recurrences. © 2016FiguresReferencesRelatedDetailsCited byTerrito A, Gallioli A, Diana P, Boissier R, Fontana M, Gaya J, Sanguedolce F, Calderón J, Piana A, Fontanet S, Algaba F, Palou J and Breda A (2022) DNA Methylation Urine Biomarkers Test in the Diagnosis of Upper Tract Urothelial Carcinoma: Results from a Single-Center Prospective Clinical TrialJournal of Urology, VOL. 208, NO. 3, (570-579), Online publication date: 1-Sep-2022. Volume 195Issue 4SApril 2016Page: e140 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Adam Wasserstrom More articles by this author Danny Frumkin More articles by this author Zohar Dotan More articles by this author Elena Bukin More articles by this author Tal Gadish More articles by this author Shiri Hanuka More articles by this author Revital Knirsh More articles by this author Abd Elhalim Darawsha More articles by this author Ilan Leibovitch More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...