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

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

1. European Urology Oncology, 2026 -- Real-World Multicentre Evaluation of GALEAS Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics
2. Microhematuria: AUA/SUFU Guideline (2020, Amended 2025)
3. the asco post — Novel Urine Biomarker Test May Reduce Unnecessary Cystoscopies in Patients With Bladder Cancer
4. The ASCO Post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
5. The ASCO Post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
6. the asco post — Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
7. Novel Urine Biomarker Test May Reduce Unnecessary Cystoscopies in Patients With Bladder Cancer
8. Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
9. Microhematuria: AUA/SUFU Guideline (2020, Amended 2025)
10. Real-World Multicentre Evaluation of GALEAS Bladder for Detecting Bladder Cancer in UK NHS Haematuria Clinics - ScienceDirect
11. Diagnostic Performance of Urinary Biomarker Tests in Detecting Bladder Cancer: A Systematic Review, Meta-analysis, and Network Meta-analysis - ScienceDirect