Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer

Inclusion Criteria: * For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older. * Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking. * Subject must have an intact bladder * Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria. * Subject must be able to provide a minimum of 25 mL of urine for study purposes. * Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR. * Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed. Exclusion Criteria: * Subject had a history or current diagnosis of any basal or squamous cell cancer. * Subject had a known diagnosis of any autoimmune disease. * Subject had known diagnosis of HIV, HCV or HBV * Subject had disclosed voluntarily history of or current infection with TB or other systemic disease. * Subject is currently pregnant or lactating. * Subject had surgery within 30 days prior to enrollment * Subject has known allergy to benzalkonium chloride. * Subject participated in an investigational drug or device trial within 30 days prior to enrollment.