MP16-15 CLINICAL VALIDATION OF URINE DNA-BASED PENK METHYLATION TEST FOR DETECTING BLADDER CANCER IN HEMATURIA PATIENTS

Abstract

You have accessJournal of UrologyBladder Cancer: Non-invasive II (MP16)1 Sep 2021MP16-15 CLINICAL VALIDATION OF URINE DNA-BASED PENK METHYLATION TEST FOR DETECTING BLADDER CANCER IN HEMATURIA PATIENTS Jae Sung Lim, Bo-Ram Bang, Justin J. Lee, Ki Hak Song, TaeJeong Oh, Yang-Yei Seo, Min A Woo, Safedin Beqaj, and Sungwhan An Jae Sung LimJae Sung Lim More articles by this author , Bo-Ram BangBo-Ram Bang More articles by this author , Justin J. LeeJustin J. Lee More articles by this author , Ki Hak SongKi Hak Song More articles by this author , TaeJeong OhTaeJeong Oh More articles by this author , Yang-Yei SeoYang-Yei Seo More articles by this author , Min A WooMin A Woo More articles by this author , Safedin BeqajSafedin Beqaj More articles by this author , and Sungwhan AnSungwhan An More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002001.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Hematuria patients are evaluated by cystoscopy to confirm the presence of bladder cancer (BCa). However, a large majority of cystoscopies are deemed unnecessary because only 5-20% of hematuria patients are diagnosed with BCa. Urine cytology has suboptimal sensitivity to triage hematuria patients for cystoscopy. As such, the development of a highly sensitive urine-based test for the early detection of BCa in hematuria patients is imperative. Our previous study identified aberrant methylation of the PENK gene (mePENK) as a specific biomarker for BCa and showed that a real-time PCR-based methylation assay for mePENK in urine sediments is a promising solution to early detection of BCa. This study was aimed to demonstrate the clinical validity of urine DNA-based mePENK assay as a useful adjunct to cystoscopy. METHODS: Two independent training and validation studies were conducted. Urine samples were collected from hematuria patients before cystoscopy or surgical treatment. Control urine samples were collected from hematuria patients without BCa. For the PENK methylation assay, two steps of PCR reactions were required: Liner Target Enrichment (LTE) and methylation specific real time PCR (qMSP) coupled with bisulfite conversion. RESULTS: The training set of the clinical study showed that sensitivity of the PENK methylation assay by LTE/qMSP was 91.0% with a specificity of 96.0% in detecting Ta high-grade and all stages of BCa from hematuria patients (Fig. 1). The prospectively designed validation study showed that the urine-based mePENK test demonstrated a sensitivity of 93.0% with a specificity of 92.0% in detecting all of Ta high-grade, Tis, and all stages of BCa from hematuria patients (Fig. 2, interim data). CONCLUSIONS: This study suggests that the urine DNA-based PENK methylation test possesses high potential to be a routine adjunct to cystoscopy in primary diagnostic settings. Use of the PENK methylation test could prevent unnecessary cystoscopy. Source of Funding: This study was sponsored by Genomictree, Inc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e302-e303 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jae Sung Lim More articles by this author Bo-Ram Bang More articles by this author Justin J. Lee More articles by this author Ki Hak Song More articles by this author TaeJeong Oh More articles by this author Yang-Yei Seo More articles by this author Min A Woo More articles by this author Safedin Beqaj More articles by this author Sungwhan An More articles by this author Expand All Advertisement Loading ...