Acu-URO17 is a highly sensitive and specific bladder cancer biomarker.

Objective: This study evaluates the efficacy of Acu-URO17, a highly sensitive and specific immunocytochemistry (ICC) test targeting Keratin 17, in comparison to urine cytology and UroVysion™ fluorescence in situ hybridization (FISH) for detecting bladder cancer cells in voided urine specimens.

Methods: Acupath conducted a large-scale comparison study using 2378 voided urine specimens. Acu-URO17, urine cytology and UroVysion™ FISH were performed on these specimens according to standardized protocols. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for Acu-URO17 in comparison to urine cytology and UroVysion™ FISH.

Results: In cases diagnosed with high-grade urothelial cancer via urine cytology, Acu-URO17 demonstrated a sensitivity of 96% and a specificity of 82%. When compared to UroVysion™ FISH results, Acu-URO17 exhibited a sensitivity of 97.1% and a specificity of 77.8%, surpassing the sensitivity of UroVysion™ FISH (57.1%). Notably, Acu-URO17 showed a high NPV of 99.9%, indicating its reliability in confirming negative urine cytology results and risk-stratifying atypical and suspicious cytology results.

Conclusion: The results of this large-scale prospective study support Acu-URO17 as a clinically relevant, non-invasive and cost-effective tool for detecting bladder cancer cells in voided urine specimens. Its high sensitivity, specificity and NPV make it a valuable adjunct to urine cytology and UroVysion™ FISH in the diagnosis and management of urothelial carcinoma (UC).