Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer

Inclusion Criteria:

- Subject is ≥ 40 years of age

- Subject has provided documented informed consent as required by the reviewing IRB or
EC. Experimental Bill of Rights will be documented for all subjects enrolled in
applicable states.

- Subject is considered disease positive within 12 months (365 days) of enrollment.

- At the time of the enrollment visit, the subject is scheduled for a standard of care
cystoscopy which will be completed within 3 days of providing a urine specimen.

- Subject has agreed to provide at least 60 mL of voided urine for study purposes at the
enrollment visit.

- Subject has agreed to provide at least 60 mL of voided urine for study purposes at
each subsequent standard of care cystoscopy visit for at least 12 months (365 days)
following enrollment if the subject will enter the Longitudinal cohort.

- Any subject considered anticipatory positive at the initial visit shall be enrolled
into the longitudinal cohort. For each anticipatory positive enrolled into the
longitudinal cohort a random disease negative subject shall be enrolled.

Exclusion

- Subject has been previously enrolled into the study.

- Urine specimen to be used for study purposes is from the first morning void.

- Subject has had an excision procedure within six weeks (42 days) of enrollment.

- The subject is not scheduled for a standard of care cystoscopy visit within 12 months
(365 days) following enrollment.