Clinical Utility of Oncuria™, a Multiplexed Liquid Biopsy for the Non-Invasive Detection of Bladder Cancer-A Pilot Study

Oncuria (TM) is a validated quantitative multiplex immunoassay capable of detecting bladder cancer from a voided urine sample. Herein, we sought to determine whether Oncuria (TM) affects physicians' use of non-invasive and invasive diagnostic tests for microhematuria, gross hematuria, and bladder cancer surveillance. We conducted a survey-based study to assess physician management of nine clinical scenarios involving real-world data from patients with gross hematuria, microhematuria, and bladder cancer on surveillance. We randomly sampled 15 practicing urologists and generated data including 135 patient-by-urologist interactions and 2160 decision points. Urologists recommended a selection of diagnostic tests and procedures before and after Oncuria (TM) results were provided. We assessed changes in provider use of non-invasive and invasive diagnostic tests after Oncuria (TM) results were provided. Over 90% of all urologists changed their diagnostic behavior in at least one patient case with the addition of Oncuria (TM) results. The total number of diagnostic procedures was reduced by 31% following the disclosure of a negative Oncuria (TM) test and 27% following the disclosure of a positive Oncuria (TM) test. This is pilot study has the potential to shed light on the analysis of our four large multicenter international studies deploying Oncuria(TM). The Oncuria (TM) urine-based test, a molecular diagnostic capable of ruling out the presence of bladder cancer, reduces both unnecessary invasive and non-invasive diagnostics and has the potential to reduce costs and improve patient outcomes.

Automated summary

This study examined the impact of Oncuria(TM) on physicians' diagnostic behavior in cases of microhematuria, gross hematuria, and bladder cancer surveillance. The results showed that over 90% of urologists changed their diagnostic behavior in at least one patient case after receiving Oncuria(TM) results. The total number of diagnostic procedures was reduced by 31% for negative Oncuria(TM) tests and 27% for positive Oncuria(TM) tests. This pilot study has the potential to provide insights for our four large multicenter international studies deploying Oncuria(TM).