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.