Phase 3 Study of Hematuria Evaluation

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.