Abstract
PURPOSE: We sought to evaluate the real-world utility of adding the Cxbladder Triage test to microhematuria diagnostic workflow in an integrated health care system. METHODS: We conducted a retrospective matched cohort study of patients with microhematuria tested with Cxbladder Triage, a urine-based biomarker of mRNA targets and clinical factors to assess urothelial cancer risk. We matched untested controls based on age, encounter date, and Hematuria Risk Index score. The cohort was stratified by Cxbladder Triage result: low probability (<4.00, cystoscopy could be deferred) vs physician-directed protocol (≥4.00, cystoscopy recommended). We evaluated the use of cystoscopy, CT urograms, and new diagnoses of bladder cancer. RESULTS: We matched 3353 patients tested with Cxbladder Triage with 3353 controls according to AUA risk (15.7% AUA low risk for cases and controls, P = .362). Among 3353 tested patients, 2670 (79.6%) had low probability of cancer and were less likely to undergo cystoscopy (3.8% vs 46.5% controls, P < .001). Tested patients with elevated risk for cancer (n = 683) were more likely to undergo cystoscopy (73.4% vs 45.7% controls, P < .001). Similar patterns were seen for the CT urogram (7.5% vs 11.7% low probability; 19.5% vs 13.3% physician-directed protocol, both P < .001). Cancer detection was similar between both groups (0.3% tested vs 0.6% controls, P = .105) and between tested patients with elevated risk vs untested controls (1.5% physician-directed protocol vs 0.6% controls, P = .107). CONCLUSIONS: Cxbladder Triage testing decreases burden of cystoscopy and CT urogram use among patients with microhematuria. This test maintains similar cancer detection overall and among patients with microhematuria at greater risk for underlying malignancy.