Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed. Participants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.
• Participants aged 45 years or older
• Participants who are willing and able to provide written informed consent and adhere to study procedures
• Participants presenting with visible and/or non-visible haematuria within 6 months prior to study enrollment
• Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment
• Participants who are able to produce at least 10 ml of voided urine