To evaluate the performance the Hematuria Cancer Risk Score (HCRS) in combination with the urine-based biomarker test Oncuria-Detect for the detection of bladder cancer in a cohort of patients referred for hematuria evaluation.

A cohort of 365 patients undergoing microscopic and gross hematuria evaluation were prospectively recruited to provide voided urine samples and pertinent clinical information. Then, retrospectively the primary outcome of sensitivity, specificity, and area under the curve (AUC) for HRCS and Oncuria for bladder cancer detection were reported.

Of the final cohort, 55 patients were diagnosed with bladder cancer and 310 served as controls. In this cohort, HCRS alone achieved a sensitivity of 90.9%, specificity of 71.9% with an AUC of 0.890 (95%CI: 0.832-0.948) and NPV of 0.978. Oncuria achieved a comparable performance with sensitivity of 78.2%, specificity of 76.8%, and an AUC of 0.838 (95%CI: 0.770-0.906) with NPV of 0.949. Evaluation using the HCRS and Oncuria in combination produced a sensitivity of 87.3% and specificity of 80.6%. The combined approach had an AUC of 0.909 (95%CI: 0.855-0.962) and NPV of 0.973. For patients with microhematuria, HCRS and Oncuria together yielded a sensitivity of 82.4% and a negative predictive value of 98.7%.

The HCRS achieves strong predictive power for the detection of bladder cancer in patients undergoing hematuria work up. The addition of the Oncuria-Detect test provides incremental improvement to this performance. Both tests can be performed at the initial primary care encounter for hematuria and may improve patient selection for cystoscopy.