The following is a summary of “Evaluation of URO17® to improve non-invasive detection of bladder cancer,” published in the March 2024 issue of Urology by Porten et al.

Bladder cancer detection traditionally relies on cystoscopy with biopsy or transurethral resection for histologic confirmation. URO17®, a promising alternative, uses a chromogenically labeled monoclonal antibody targeting keratin 17 (k17), a cytoskeletal molecule linked with bladder, pancreatic, and cervical cancers. Initial investigations into k17’s efficacy have demonstrated notable sensitivity and specificity in detecting bladder cancer, warranting deeper investigation. 

The objective was to assess the sensitivity and specificity of URO17. This cross-sectional study, conducted from July 6, 2018, to July 17, 2019, at a single institution, involved participants undergoing various urologic procedures. Cases consisted of individuals undergoing cystectomy or endoscopic procedures for suspected urothelial carcinoma, while controls underwent urologic interventions for unrelated reasons. Voided urine samples were collected during the procedure, with some participants contributing up to three samples due to multiple resections. Blinded testing with URO17 was performed, and sensitivity and specificity were calculated. Among 152 participants contributing 167 samples, URO17 demonstrated an overall sensitivity of 90% and 92% and a specificity of 88% and 87%, respectively. Within the subgroup of 76 participants and 91 samples suspected of urothelial carcinoma, sensitivity remained consistently high at 90% and 92%, with specificities of 50% and 54%. 

Notably, no controls showed a positive URO17 result, and URO17 outperformed urine cytology in detecting low-grade and high-grade Ta cancers. False positives were predominantly associated with inflamed tissue or urothelial atypia, often linked with prior intravesical therapy. While acknowledging limitations such as the cross-sectional design and convenience sampling, the findings suggest URO17’s potential to enhance urine cytology’s sensitivity in urothelial cancer detection. Nevertheless, further research is warranted to refine its clinical application.

Source: sciencedirect.com/science/article/pii/S1078143924003454