Inclusion Criteria:  

• Age >18 years 

• Patient undergoing evaluation for suspicion of, or exclusion of, bladder neoplasm 

Exclusion Criteria:  

• Patient has known cancer outside of the target cancer 5 years prior to current blood collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible) 

• Patient has received chemotherapy class drugs in the 5 years prior to current blood collection 

• Patient has had any prior radiation therapy to the target lesion prior to current blood collection 

• Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection 

• Patient has undergone cystectomy  

• Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within 7 days prior to sample collection  

• Patient has had a urinary tract infection within 14 days prior to urine collection  

• Patient has chronic indwelling urinary catheter