Pd41-07 Assessment of the Diagnostic Accuracy of Oncuria-Detect ® for Detection of Upper Tract Urothelial Carcinoma

You have accessJournal of UrologyBladder Cancer: Upper Tract Transitional Cell Carcinoma III (PD41)1 May 2024PD41-07 ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF ONCURIA-DETECT® FOR DETECTION OF UPPER TRACT UROTHELIAL CARCINOMA Toru Sakatani, Kazutoshi Fujita, Jennifer Linehan, Kaoru Murakami, Riko Lee, Ian Pagano, Charles Rosser, and Hideki Furuya Toru SakataniToru Sakatani , Kazutoshi FujitaKazutoshi Fujita , Jennifer LinehanJennifer Linehan , Kaoru MurakamiKaoru Murakami , Riko LeeRiko Lee , Ian PaganoIan Pagano , Charles RosserCharles Rosser , and Hideki FuruyaHideki Furuya View All Author Informationhttps://doi.org/10.1097/01.JU.0001008568.76803.f1.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Due to insufficient accuracy, urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC). The application of a robust urine-based multiplex assay, Oncuria-Detect®, to aid in the detection of UTUC has the potential to address this deficiency and to assist with accurate, non-invasive diagnosis. METHODS: To evaluate the performance of Oncuria-Detect®, a multiplex immunoassay capable of querying a voided urine sample for 10 protein biomarkers associated with urothelial carcinoma (A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA). Its application to UTUC was evaluated in a multi-institutional cohort of 35 prospectively collected subjects presenting for evaluation of upper tract mass along with 46 prospective collected matched controls (i.e., non-tumor bearing). The ability of the test to identify patients harboring UTUC was assessed. UTCU status was confirmed by endoscopy and tissue biopsy or definitive surgery. Diagnostic performance was assessed using ROC curves. RESULTS: Oncuria-Detect® provided an AUC of 0.886 (95% CI: 0.807-0.964) with an overall sensitivity of 91.4%, specificity of 73.9%, NPV 91.9% and PPV 72.7%. Sensitivity values of the diagnostic panel for low-grade UTUC, high-grade UTUC, non-invasive UTUC and invasive UTUC were 86.7%, 90.9%, 88.9% and 94.1%, respectively. Urinary cytology or selective ureteral washing/cytology was associated with an overall sensitivity of 54.2%, specificity of 100%, NPV 63.3% and PPV 100%. Sensitivity values of cytology for low-grade UTUC, high-grade UTUC, non-invasive UTUC and invasive UTUC were 100%, 100%, 100%, and 77.8%, respectively. CONCLUSIONS: Urinary levels of a biomarker panel enabled the accurate discrimination of UTUC and controls non-tumor bearing individuals. The multiplex Oncuria-Detect® test can achieve the efficient and accurate detection of UTUC in a non-invasive patient setting. Download PPT Source of Funding: NIH/NCI R01CA198887 (CJR), UH3CA271377 (CJR), U54CA274375 (CJR/HF), R01CA277810 (CJR/HF), and R21CA263230 (HF) © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e888 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Toru Sakatani More articles by this author Kazutoshi Fujita More articles by this author Jennifer Linehan More articles by this author Kaoru Murakami More articles by this author Riko Lee More articles by this author Ian Pagano More articles by this author Charles Rosser More articles by this author Hideki Furuya More articles by this author Expand All Advertisement PDF downloadLoading ...