Clinical Report: Urine Bladder Cancer Test Could Triage Cystoscopy
Overview
A urine-based DNA test, the GALEAS Bladder assay, demonstrated high sensitivity in detecting bladder cancer, identifying 71 of 77 cases with a negative predictive value exceeding 99%.
Background
Hematuria, or blood in the urine, is a common symptom prompting cystoscopy, an invasive procedure that many patients referred for it do not have bladder cancer. The GALEAS Bladder assay offers a molecular testing approach to determine which patients require urgent investigation.
Data Highlights
| Parameter | Value |
|---|---|
| Detected bladder cancers | 71 of 77 |
| Negative predictive value | Exceeding 99% |
| Positive predictive value | 50% |
| Muscle-invasive cancers detected | 17 of 17 |
| High-grade cancers detected | 35 of 36 |
| Non-cancer samples correctly classified | 816 of 887 |
Key Findings
- The GALEAS Bladder assay detected 71 out of 77 bladder cancers.
- It achieved a negative predictive value of more than 99%.
- All muscle-invasive cancers were detected, along with 35 of 36 high-grade cancers.
- Among patients without bladder cancer, 816 out of 887 tested negative.
- The positive predictive value was 50%.
- Modeling suggested a potential reduction of 730 urgent cystoscopies per 1000 patients.
Clinical Implications
The GALEAS Bladder assay could serve as a triage tool to prioritize patients for cystoscopy based on their risk of bladder cancer.
Conclusion
The findings indicate that molecular testing may play a role in the triage of patients with hematuria.
Related Resources & Content
- European Urology Oncology, 2026 -- Real-World Multicentre Evaluation of GALEAS Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics
- Microhematuria: AUA/SUFU Guideline (2020, Amended 2025)
- the asco post — Novel Urine Biomarker Test May Reduce Unnecessary Cystoscopies in Patients With Bladder Cancer
- The ASCO Post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
- The ASCO Post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
- the asco post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
- Novel Urine Biomarker Test May Reduce Unnecessary Cystoscopies in Patients With Bladder Cancer
- Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
- Microhematuria: AUA/SUFU Guideline (2020, Amended 2025)
- Real-World Multicentre Evaluation of GALEAS Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics - ScienceDirect
- Diagnostic Performance of Urinary Biomarker Tests in Detecting Bladder Cancer: A Systematic Review, Meta-analysis, and Network Meta-analysis - ScienceDirect
Based on findings from:
Urine Bladder Cancer Test Could Triage Cystoscopy
The Pathologist, 2026.
https://www.thepathologist.com/issues/2026/articles/september/urine-bladder-cancer-test-could-triage-cystoscopy/
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