Multi Institutional Study in Patient Presenting With Hematuria

The primary objective of this study is to evaluate the performance of the methylation marker
panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

The secondary objective is to evaluate the predictive accuracy of a risk model including
clinical factors such as age, gender, smoking history, and presence of gross versus
microscopic hematuria compared to a model incorporating the same risk factors along with the
methylation marker panel.

Inclusion Criteria:

1. Subject is willing and able to give written informed consent

2. Subject presents with or has a history of gross hematuria or microhematuria within the
last 3 months

Exclusion Criteria:

1. Subject has an active urinary tract infection, current urinary retention, active stone
disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel
interposition, or recent genitourinary instrumentation (within 10 days)

2. Subject has a current or past history of genitourinary or urologic cancer within 5
years

3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer
within 5 years