Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is: • Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results? Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.
• Patients ≥ 18 years of age at time of informed consent.
• Subject or the subject's legally authorized representative provides written informed consent.
• Subject is willing to follow all study procedures and available for the duration of the study.
• Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
• Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
• Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology.