{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T19:33:40Z","timestamp":1783625620374,"version":"3.55.0"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,10,20]],"date-time":"2020-10-20T00:00:00Z","timestamp":1603152000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction and objectives<\/jats:title><jats:p>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\u2122 urinary biomarker for the detection of urothelial cancer in hematuria patients in a prospective blinded validation study. Uro17\u2122 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\u2122 results in patients being investigated for symptoms of urothelial cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>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\u2122 immunobiomarker. The pathologists assessing the results were blinded to the patient and background history, and the results were compared to the biopsy histology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010smokers, and 16 nonsmokers. The malignancies detected included both muscle\u2010invasive (n\u00a0=\u00a06) and non\u2010muscle\u2010invasive tumors (n\u00a0=\u00a038), and tumors of all grades and carcinoma in situ. Uro17\u2122 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\u2122 investigation was positive in every case of urothelial malignancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our current data indicates Uro17\u2122 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.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bco2.50","type":"journal-article","created":{"date-parts":[[2020,10,20]],"date-time":"2020-10-20T14:50:17Z","timestamp":1603205417000},"page":"46-52","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["The role of URO17\u2122 biomarker to enhance diagnosis of urothelial cancer in new hematuria patients\u2014First European Data"],"prefix":"10.1002","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3966-5734","authenticated-orcid":false,"given":"Nikhil","family":"Vasdev","sequence":"first","affiliation":[{"name":"Hertfordshire and Bedfordshire Urological Cancer Centre Department of Urology Lister Hospital Stevenage UK"},{"name":"School of Life and Medical Sciences University of Hertfordshire Hatfield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3517-2534","authenticated-orcid":false,"given":"Alexander","family":"Hampson","sequence":"additional","affiliation":[{"name":"Hertfordshire and Bedfordshire Urological Cancer Centre Department of Urology Lister Hospital Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samita","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Department of Pathology Lister Hospital Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Swamy","sequence":"additional","affiliation":[{"name":"Department of Pathology Lister Hospital Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chilvers","sequence":"additional","affiliation":[{"name":"Department of Anaesthetics Lister Hospital Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Hampson","sequence":"additional","affiliation":[{"name":"Hertfordshire and Bedfordshire Urological Cancer Centre Department of Urology Lister Hospital Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sholeh","family":"Jahanfard","sequence":"additional","affiliation":[{"name":"KDx Diagnostics Inc Campbell CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nam","family":"Kim","sequence":"additional","affiliation":[{"name":"KDx Diagnostics Inc Campbell CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,20]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2018.07.005"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2016.06.010"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp14X681409"},{"key":"e_1_2_6_5_1","first-page":"76","article-title":"Cancer facts & figures 2020","author":"American Cancer Society","year":"2020","journal-title":"American Cancer Society"},{"key":"e_1_2_6_6_1","article-title":"Urinary biomarkers in bladder cancer: a review of current landscape and future applications","author":"Ng K","year":"2020","journal-title":"Urologic Oncology: Seminars and Origional Investigtions"},{"key":"e_1_2_6_7_1","unstructured":"Urological cancers\u2014recognition and referral\u2014NICE CKS. 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