Abstract A070: Diagnostic accuracy of Oncuria®-Detect in the detection of upper tract urothelial tumors

Abstract Due to insufficient accuracy, urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma. The robust urine-based multiplex assay for diagnosis of upper tract urothelial carcinoma has the potential to address this deficiency and to assist with accurate, non-invasive diagnosis.We previously developedOncuria®-Detect, a multiplex immunoassay capable of detecting bladder cancer using a single voided urine. In this study, its application to upper tract urothelial cancer was evaluated in a multi-institutional cohort of 61 prospectively collected subjects presenting for evaluation of upper tract mass along with 61 prospective collected matched controls. The ability of the test to identify patients harboring upper tract urothelial carcinoma was assessed. Cancer status was confirmed by endoscopy and tissue biopsy or definitive surgery. Oncuria®-Detect provided an AUC of 0.868 (95% CI: 0.802- 0.933) with an overall sensitivity of 96.7%, specificity of 59.0%, NPV 94.7% and PPV 70.2%. Sensitivity values of Oncuria®-Detect for low-grade, high-grade, non-invasive and invasive upper tract urothelial cancer were 100%, 89.7%, 93.3% and 96.2%, respectively. Voided urine cytology showed an overall sensitivity of 54.5%, specificity of 100%, NPV 31.0% and PPV 100%. As a non-invasive test, Oncuria®-Detect outperformed both voided urinary cytology and selective cytology (sensitivities 96.7% vs. 54.5% vs. 81.8%, respectively). Oncuria®-Detect enabled the accurate discrimination of upper tract urothelial carcinoma and controls non-tumor bearing individuals. The Oncuria®-Detect test can achieve the efficient and accurate detection of upper tract urothelial carcinoma in a non-invasive patient setting. Citation Format: Kazutoshi Fujita, Makito Miyake, Takuto Shimizu, Jennifer Linehan, Joshua Gottlieb, Ian Pagano, Sergei Tikhonenkov, Kaoru Murakami, Riko Lee, Toru Sakatani, Sunao Tanaka, Charles J Rosser, Hideki Furuya. Diagnostic accuracy of Oncuria®-Detect in the detection of upper tract urothelial tumors [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A070.