The following is a summary of “Diagnostic Accuracy Of Oncuria-Detect In The Detection Of Upper Tract Urothelial Tumors,” published in the April 2023 issue of Urology by Fujita et al.
Urine-based assays lack sufficient accuracy in managing patients with upper tract urothelial cancers (UTUC). This study aimed to assess the effectiveness of Oncuria™-Detect, a multiplex immunoassay capable of analyzing voided urine samples for 10 protein biomarkers linked with urothelial carcinoma. The investigation involved a multi-institutional cohort of 31 subjects presenting with upper tract masses and 41 matched controls without tumors. UTUC confirmation was through endoscopy, tissue biopsy, or definitive surgery. Diagnostic performance was evaluated using ROC curves.
The Oncuria™-Detect demonstrated an AUC of 0.897 (95% CI: 0.817-0.977) with a sensitivity of 93.5%, specificity of 75.6%, NPV of 93.9%, and PPV of 74.4%. Sensitivity for high-grade UTUC, low-grade UTUC, non-invasive UTUC, and invasive UTUC was 88.9%, 92.3%, 86.7%, and 100%, respectively. In contrast, urinary cytology or selective ureteral washing/cytology exhibited an overall sensitivity of 58.3%, specificity of 100%, NPV of 79.2%, and PPV of 100%. Specific sensitivity values for cytology regarding different UTUC grades were 50%, 100%, 80%, and 42.9%, respectively.
This study highlights the efficiency of a biomarker panel in accurately discerning UTUC from non-tumor-bearing individuals. Oncuria™-Detect, through its multiplex analysis, offers a promising and non-invasive approach to efficiently and accurately detect UTUC in clinical settings.