Urine Bladder Cancer Test Could Triage Cystoscopy
Real-world UK study suggests molecular testing could help prioritize patients with hematuria for urgent bladder investigation
Objective:
To evaluate the effectiveness of the GALEAS Bladder assay in triaging patients with hematuria for urgent cystoscopy.
Approach:
- Study Design: A prospective, multicenter UK study involving patients referred for urgent hematuria investigation at seven NHS urology departments.
- Test Methodology: The GALEAS Bladder assay uses next-generation sequencing to detect mutations associated with bladder cancer in urine DNA.
Key Findings:
- The assay detected 71 of 77 bladder cancers with a negative predictive value exceeding 99%.
- It identified all 17 muscle-invasive cancers and 35 of 36 high-grade cancers.
- Among 887 patients without bladder cancer, 816 tested negative.
- The overall positive predictive value was 50%.
- Modeling indicated a potential reduction of 730 urgent cystoscopies per 1000 patients.
Limitations:
- Incomplete follow-up for patients with positive molecular results but negative standard investigations.
- Randomized evidence is needed before urinary biomarkers can be recommended as replacements for cystoscopy.
Sources:
