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

Subjects will be selected from Urology and Oncology practices.

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.