The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data

Abstract

Introduction and objectives Novel biomarker research is vital for the progression of safe and thorough diagnostic medicine. There is now a need to improve the diagnosis of bladder cancer via a noninvasive urine test while balancing the risks of harm from investigational procedures, such as cystoscopy and radiological tests, against the likelihood of malignancy. We evaluate the diagnostic accuracy and sensitivity of Uro17™ urinary biomarker for the detection of urothelial cancer in hematuria patients in a prospective blinded validation study. Uro17™ is an immunobiomarker which binds to the oncoprotein Keratin 17, which is involved in the replication cycle of malignant cells. This study compared cystoscopic and histological investigations against Uro17™ results in patients being investigated for symptoms of urothelial cancer. Materials and methods After receiving both local and national ethics/protocol approval, 71 patients were consented and recruited into the study. All patients were scheduled to undergo cystoscopic investigation, and following recruitment, a urine sample was collected. Urine samples were anonymized and processed as per standard cytology protocols and stained using Uro17™ immunobiomarker. The pathologists assessing the results were blinded to the patient and background history, and the results were compared to the biopsy histology. Results The full cohort of enrolled patients consisted of 71 participants included. There were 55 males and 16 females, with an average age of 70. Thirteen were current smokers, 42 ex‐smokers, and 16 nonsmokers. The malignancies detected included both muscle‐invasive (n = 6) and non‐muscle‐invasive tumors (n = 38), and tumors of all grades and carcinoma in situ. Uro17™ was shown to have an overall sensitivity of 100% and a specificity of 92.6%, with a positive predictive value of 0.957 and negative predictive value of 1. Uro17™ investigation was positive in every case of urothelial malignancy. Conclusions Our current data indicates Uro17™ is a highly sensitive noninvasive bladder cancer urine detection test that can improve the diagnosis of Bladder cancer. This can further improve diagnostic capabilities in primary care, reduce the number of referrals to Urology department, and reduce the number of unnecessary invasive procedures for new patients with a suspected urinary bladder cancer.

Biomarkers in Bladder Cancer Surveillance

“…Babu et al had identified high sensitivity and specificity of URO17 of 100% using urine samples in a retrospective study ( 44 ). Interestingly, URO17 is able to detect both low and high grade cancers in patients presenting with haematuria, a previously excluded cohort, thus proving its benefit of use in a surveillance setting as well ( 45 ). There is a specificity of 96 and 92.7% in recurrent and newly diagnosed patients, respectively ( 44 , 45 ).…”

“…Interestingly, URO17 is able to detect both low and high grade cancers in patients presenting with haematuria, a previously excluded cohort, thus proving its benefit of use in a surveillance setting as well ( 45 ). There is a specificity of 96 and 92.7% in recurrent and newly diagnosed patients, respectively ( 44 , 45 ). Given these outcomes and its easy adaptation to current equipment used, a larger prospective study in a surveillance setting would be beneficial in developing this into a promising protein biomarker test for non-invasive surveillance of NMIBC ( 45 , 46 ).…”

The great escape: A tale of the visiting professor’s Artful Dodge

“…Vasdev et al, 1 on a novel biomarker for urothelial cancer, and hence our theme of screening metrics. The cohort tested is a modest size of 71, but the overall sensitivity was 100% with specificity of 92.6%, and PPV 0f 95.7%.…”

Urinary biomarkers to mitigate diagnostic delay in bladder cancer during the COVID-19 era

“…8 ), shows promise in its diagnostic capability. This immunocytochemistry-based test detects the presence of oncoprotein Keratin 17 (K17)a protein involved in the replication cycle of malignant cells -in urothelial cells and has demonstrated a sensitivity of 100% in detection of both recurrent bladder cancer 9 and new bladder tumours from patients presenting with haematuria; the specificity of URO17 in the detection of recurrent and new bladder cancer was 96% and 92.6%, respectively 8 . These data suggest that URO17 could be a sensitive and specific test for papillary urothelial neoplasm of low malignant potential, as well as both papillary and nonpapillary carcinomas, providing diagnostic value in cases that could be missed by urine cytology.…”

“…Additionally, URO17 can be used to test patients presenting with haematuria, a cohort of patients that had not been included in previous studies of K17 tests, thereby expanding its use in the surveillance population. Notably, the immunocytochemical assay required for URO17 is easily adaptable to existing instruments and uses the same samples as used in urine cytology, thereby enabling its integration into clinical practice 8,9 .…”