Study of performance of Cxbladder tests to indicate whether patients are at low or high risk of bladder cancer when presenting with blood in urine.

This is a prospective study recruiting patients presenting with blood in urine who are undergoing urological investigation for the presence of bladder cancer. This study is designed to highlight the utility of the Cxbladder tests in an Australian clinical setting by demonstrating performance characteristics in a clinical practice. Results of the Cxbladder test will be correlated with the outcome of investigative cystoscopy, which is the standard of care for patients presenting with blood in urine. A urine sample will be collected prior to the investigative cystoscopy (either immediately prior or several days prior depending on whether the patient is having a flexible or rigid cystscopy). There are 3 Cxbladder tests to be evaluated in this study, - Cxbladder Triage, which is designed to rules out the presence of bladder cancer in patients presenting with blood in urine at an early stage, thereby potentially avoiding invasive cystoscopy; - Cxbladder Detect, which is used in detection of bladder cancer in patients with blood in urine; and - Cxbladder Resolve is designed to accurately segregate patients being evaluated for blood in urine with a high probability of high grade and/or late stage UC, from patients with low or minimal risk of the disease. For the patient, each of these test just require a mid-stream urine test for analysis and collection of clinical information. Each algorithm (Detect, Triage & Resolve) uses different combinations of the analysis outputs and clinical data. The study will be conducted in two stages, Stage 1: patient data and urine sample collection and Stage 2: Review of patient records for patients that had negative cystoscopy result.