The American Urological Association (AUA) currently recommends cystoscopy for most patients over 40 with microhematuria (≥3 RBC/hpf) due to the associated urothelial cancer (UC) risk, estimated at 2-5%. Cxbladder Triage, an mRNA-based urinary test, has a 99% negative predictive value for UC, potentially reducing unnecessary cystoscopies. This study presents interim findings from a multicenter, randomized controlled trial that compares cystoscopy as the standard of care (SOC) with a genomic marker-based approach using Cxbladder Triage. In the study, patients with asymptomatic microhematuria provided urine samples for Cxbladder testing. Those deemed “low risk” (LR)—defined as 3-29 RBC/hpf and minimal smoking history (0-10 pack years)—were randomized in a 2:1 ratio to either a Triage test-informed group or a SOC group requiring cystoscopy. Patients with a negative Triage result had the option to skip cystoscopy and undergo surveillance using markers, urine cytology, and abdominal ultrasound.
Among the 449 enrolled patients, 205 were classified as LR, with 132 in the Triage arm and 73 in the SOC arm, yielding complete data for 147 participants. The median age was 56 years (range 18-90), with 48% male. In the SOC group, 64% (38/59) underwent cystoscopy. In the Triage arm, 90% (79/88) received a negative result, and only 31% opted for cystoscopy, representing a 52% reduction in cystoscopy rates compared to SOC (p=0.00005). Notably, only one UC case was detected, in a patient with a positive Triage result. This study highlights the potential of Cxbladder Triage to significantly reduce cystoscopy in low-risk patients with microscopic hematuria, minimizing patient discomfort, enhancing healthcare access, and reducing environmental impact.
