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 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

Subject presents with or has a history of gross hematuria or micro hematuria within the last 3 months