Diagnostic Accuracy of the Oncuria-Detect Multiplex Immunoassay in Detecting Upper Tract Urothelial Carcinoma

Urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC), due to insufficient accuracy. This study evaluated a multiplex urine assay designed to accurately and non-invasively diagnose UTUC. Oncuria-Detect is a multiplex immunoassay capable of detecting urothelia cancer using a single voided urine specimen. In the current multi-institutional study, we tested the assay's utility in identifying UTUC in 60 subjects presenting for evaluation of upper tract mass compared with samples from 60 age-, sex-, and race-matched controls. Cancer status was confirmed via histopathological assessment of tissue specimens obtained during ureteroscopy/biopsy or at the time of definitive surgical intervention (nephroureterectomy or ureterectomy). For detecting UTUC, Oncuria-Detect provided an AUC of 0.77 (95% CI: 0.70-0.84) with an overall sensitivity of 93%, specificity of 55%, negative predictive value (NPV) 89%, and positive predictive value (PPV) 67%. Assay sensitivity values for low-grade, high-grade, non-invasive, and invasive UTUC were 94%, 93%, 93% and 92%, respectively. Voided urine cytology showed an overall sensitivity of 54%, specificity of 100%, NPV 31.0%, and PPV 100%. Selective (upper tract) cytology had a sensitivity of 80%. Oncuria-Detect outperformed both non-invasive voided urinary cytology and invasive selective cytology in overall assay performance. Oncuria-Detect accurately identified and categorized UTUC and discriminated patients with cancer from non-tumor bearing individuals. The Oncuria-Detect test provides a rapid, accurate, and non-invasive method for detecting UTUC.