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Cxbladder Triage in the Evaluation of Microhematuria

Microhematuria is a common clinical finding that frequently prompts urologic evaluation, yet the incidence of underlying urothelial malignancy remains low, particularly among patients without high-risk features. The 2025 AUA/SUFU Microhematuria Guideline recommends a risk-stratified approach to evaluation based on demographic and clinical factors, though cystoscopy and cross-sectional imaging remain part of the diagnostic pathway for many patients.

Cxbladder Triage is a noninvasive urine-based molecular test designed to further refine malignancy risk assessment in patients with microhematuria. Recent real-world data provide insight into how incorporation of this test may affect diagnostic utilization while maintaining cancer detection.

Clinical Takeaway

Cxbladder Triage is a urine-based molecular assay that may reduce cystoscopy and CT urogram utilization in patients with microhematuria while preserving bladder cancer detection when used as an adjunct to guideline-based risk stratification.

Diagnostic Test Profile

  • Test Name: Cxbladder Triage
  • Specimen: Urine
  • Methodology: Quantitative mRNA biomarker analysis combined with clinical risk variables
  • Output: Numerical score stratifying patients by probability of urothelial cancer
    • Low probability: <4.0 (cystoscopy may be deferred)
    • Elevated probability: ≥4.0 (physician-directed evaluation recommended)
  • Clinical Role: Risk-based triage tool intended to identify patients unlikely to benefit from immediate invasive evaluation

Target Population

  • Adults undergoing evaluation for microhematuria
  • Patients categorized as low or intermediate risk under AUA/SUFU guidelines
  • Individuals in whom cystoscopy deferral is being considered based on overall malignancy risk

Matched Cohort Study Design (Filson et al., 2026)

  • Study Type: Retrospective matched cohort study
  • Setting: Integrated healthcare system
  • Population:
    • 3,353 patients evaluated with Cxbladder Triage
    • 3,353 matched untested controls
  • Matching Criteria:
    • Age
    • Encounter date
    • Hematuria risk index score
  • Risk Distribution:
    • AUA low-risk patients: 15.7% in both groups (p = 0.362)
  • Comparator: Standard microhematuria evaluation without biomarker testing

Key Endpoints

  • Primary Endpoint:
    • Utilization of cystoscopy
  • Key Secondary Endpoints:
    • Utilization of CT urogram
    • New diagnosis of bladder cancer

Clinical Decision Impact Outcomes

  • Among patients evaluated with Cxbladder Triage:
    • 79.6% (n = 2,670) were classified as low probability for urothelial cancer
    • 20.4% (n = 683) were classified as elevated probability
  • Cystoscopy Utilization:
    • Low probability group:
      • 3.8% underwent cystoscopy vs 46.5% of matched controls (p < 0.001)
    • Elevated probability group:
      • 73.4% underwent cystoscopy vs 45.7% of controls (p < 0.001)
  • CT Urogram Utilization:
    • Low-probability group:
      • 7.5% vs 11.7% in controls (p < 0.001)
    • Elevated-probability group:
      • 19.5% vs 13.3% in controls (p < 0.001)

These findings demonstrate reduced diagnostic intensity in low-probability patients with selective escalation of evaluation in higher-risk individuals.

Cancer Detection Outcomes

Bladder cancer detection rates were similar between Cxbladder Triage–tested patients and matched controls.

  • Overall:
    • 0.3% in tested patients vs 0.6% in controls (p = 0.105)
  • Higher-risk subgroups:
    • 1.5% in patients with elevated Cxbladder Triage scores vs 0.6% in controls (p = 0.107)

Despite reduced use of invasive testing, no statistically significant difference in cancer detection was observed.

Key Clinical Implications

Supports refinement of guideline-based microhematuria evaluation

Reduces low-yield cystoscopy and imaging in selected patients

Preserves diagnostic vigilance in patients at higher risk for malignancy

Aligns with value-based and patient-centered care initiatives

Bottom Line

In a real-world matched cohort, incorporation of Cxbladder Triage into the evaluation of microhematuria substantially reduced cystoscopy and CT urogram utilization while maintaining comparable bladder cancer detection, supporting its role as an adjunct to AUA/SUFU guideline–directed risk stratification.

Sources:

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