Evaluation of URO17® to improve non-invasive detection of bladder cancer

Area of Science:

• Uro-oncology
• Biomarker discovery
• Cancer diagnostics

Background:

• Cystoscopy with biopsy is the gold standard for bladder cancer diagnosis.
• Keratin 17 (k17) is a biomarker associated with bladder, pancreatic, and cervical cancers.
• Preliminary studies suggest k17 has high sensitivity and specificity for bladder cancer detection.

Purpose of the Study:

• To evaluate the diagnostic accuracy of URO17, a monoclonal antibody test for keratin 17 (k17).
• To determine the sensitivity and specificity of URO17 in detecting bladder cancer.

Main Methods:

• A cross-sectional study involving 152 participants undergoing urologic procedures.
• Voided urine samples were collected and tested with URO17 in a blinded manner.
• Sensitivity and specificity were calculated for URO17 detection of urothelial carcinoma.

Main Results:

• URO17 demonstrated an overall sensitivity of 90-92% and specificity of 87-88%.
• In patients with suspected urothelial carcinoma, sensitivity was 90-92% and specificity was 50-54%.
• URO17 outperformed urine cytology for low-grade and high-grade Ta tumors; no false positives in controls.

Conclusions:

• URO17 shows promise for improving urothelial carcinoma detection sensitivity compared to urine cytology.
• Further research is needed to refine URO17's clinical application as a bladder cancer biomarker.
• False positives were linked to inflamed tissue, urothelial atypia, or prior intravesical therapy.