TEST:

URO17™

Current data on multiple independent studies confirms that URO17® is a highly sensitive NMIBC urine detection test that could help screen patients for bladder cancer in the community with minimal resources required. This can improve diagnostic capabilities in primary care and reduces the number of unnecessary invasive investigations. URO17® exhibits a high level of sensitivity and specificity in both recurrent UC and new UC in hematuria populations.

MP-10.01 Diffusion-Weighted Magnetic Resonance Imaging for Assessment of Tumor Response in Muscle-Invasive Bladder Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Prospective StudyAbbas Basiri, Iran, Islamic Rep. MP-10.02 Divergent Experiences of Bladder Cancer Patients: A Focus on Advanced and Metastatic Disease StagesAlex Filicevas, Belgium MP-10.03 Evolution of a Rapid, Simple Urine Test for Detecting Volatile Organic Compound (VOC) in Urine by a High Performance Portable Device (NABIL) for Detection of Urinary Bladder CarcinomaSaurav Karmakar, India MP-10.04 Intraoperative ICG Fluorescence as a Method of Prevention of Postoperative Strictures of Uretero-Ileoanastomoses During Robot-Assisted Radical CystectomyValentin Pavlov, Russian Federation MP-10.05 Intravesical Gemcitabine and Docetaxel in Patients with High Risk NMIBC: Our ExperienceDeepak Krishnappa, India MP-10.06 On Block Robot-Assisted Radical Cystectomy: New Method for Bladder CancerValentin Pavlov, Russian Federation MP-10.07 Oncological Outcomes with the 80mg Dose of the Moscow Strain of Intravesical BCG for Non-Muscle Invasive Bladder Cancer: Implications for Global ShortageAmandeep Arora, India MP-10.08 Outcome of Robot-Assisted Radical Cystectomy with Intracorporeal Creation of Heterotopic NeocystisValentin Pavlov, Russian Federation MP-10.09 Proposed Novel Surveillance Schedule Using Cx Monitor for Patients on Annual Bladder Cancer SurveillanceArjun Guduguntla, Australia MP-10.10 Quality of Primary TURBTs for Non-Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.11 TAR-200 in Patients with Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results from the SunRISe-1 StudyAndrea Necchi, United States MP-10.12 Timeline Analysis of Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.13 Transurethral Resection of Bladder Tumour (TURBT) Operative Notes: How to Improve Their QualitySaurabh Verma, United Kingdom MP-10.14 Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer Following Transurethral Resection of Bladder TumorRobert Svatek, United States MP-10.15 URO17® Urine Test For Bladder Cancer - Meta AnalysisNikhil Vasdev, United Kingdom MP-10.16 Usefulness of UF-5000 Automatic Screening System in Urothelial Carcinoma DiagnosisTadahiko Kikugawa, Japan MP-10.17 Validation of Novel ddPCR Bladder Cancer DNA Mutation Panels in Liquid BiopsiesAntara Karmakar, Australia

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 UroVysionâ„¢ FISH in the diagnosis and management of urothelial carcinoma (UC).

In short, find a marker that can specificly diagnose bladder cancer at initial stages without needing more elaborate, usually invasive tests, is shown as a promising tool for studies in this area.

Limitations include cross-sectional design and convenience sampling. URO17 may improve sensitivity of urine cytology in the detection of urothelial cancer, though further study is required to refine the application of this biomarker in clinical practice.

URO17® has a potential to be a reliable test for diagnosis and follow up of urothelial cancer patients and a screening tool adjunct to flexible cystoscopy.

The greatest increase was seen in the proportion of patients unwilling to accept a urinary biomarker regardless of its sensitivity, rising from 29.6% to 38.4%. Although many patients attending a RAHC would be willing to accept a urinary biomarker test in place of conventional flexible cystoscopy for the detection of bladder cancer, effective patient, public and clinician engagement will be necessary at all stages of implementation if it is to become an established component of the diagnostic pathway.

Keratin 17 is highly expressed in almost all cases of urothelial carcinoma including those of papillary and squamous characteristics, confirming the high sensitivity of K17 in detecting all categories of urothelial carcinoma. Keratin 17 was also observed in many benign and premalignant conditions such as cystitis, PUNLMP, and metaplasia suggesting the K17 expression can result from a trauma to urothelium that could lead to activation of K17 in regenerating urothelial cells. Additional studies are ongoing to confirm and expand the utility of the K17 biomarker in bladder cancer.

"Acupath Labs and UroGPO announced in April a partnership to make URO17® available to the UroGPO membership nationwide. URO17® is a non-invasive, cost-effective urine-based biomarker used in diagnosis and management of bladder cancer....With a high sensitivity and negative predictive value (NPV), URO17 can provide invaluable information and help clinicians better risk stratify patients, identifying those that require additional and often invasive follow up treatments, and those that do not."