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:

• European Urology Oncology