Phase 3 Study of Bladder Cancer Recurrence Surveillance

Inclusion Criteria:

- Intact bladder

- Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening

- Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical
therapy, radiation or TUR

- Must be willing to sign IRB approved informed consent

Exclusion Criteria:

- History or current diagnosis of any cancer except transitional cell bladder cancer or
basal cell cancer

- Known diagnosis of any autoimmune disease or HIV, HCV or HBV

- History or current TB or any other active infection

- Subject has gross hematuria

- Receiving chemotherapy, intravesical therapy or radiation within 30 days of
enrollment

- Any surgery except urologic within past 30 days