• To measure the change in total procedure use (and the invasive procedure sub-group) count between control and test arms when Cxbladder is used in the evaluation. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To evaluate the increase in utility as defined by the reduction in total procedures (and the invasive procedures subgroup) count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis.
• To measure the proportion of subjects who were ruled out on the test arm when Cxbladder is used in the evaluation [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To quantify the 'rule-out' percentage (proportion ruled out from further evaluation by the physician) when Cxbladder is used in the evaluation.
• To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To quantify the false negative rate (the percentage of the negative fraction incorrectly diagnosed) associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC
• Proportion of subjects (and sub-groups within test and control arms) with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients referred for evaluation of hematuria.
• To compare the total score of the anxiety and pain level associated with cystoscopy vs Cxbladder by using Patient Result Outcome questionnaire and WIWI(was it worthy it) [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  Subjects will have Patient Reported Outcomes at enrollment for all subjects on the test arm to set a baseline and post cystoscopy for all subjects on the test arm. For all of the PROMIS short forms we will report PROMIS T-scores. For both measures, the raw score will be converted to a T-score which rescales the raw score into a standardized score that ranges from 0 to 100 with a mean of 50 and a standard deviation of 10. Anxiety level has four questions with five scales of answers. Pain level has three questions with five scales of answers. WIWI has 6 questions on the three scales to describe answers.
• Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively. Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.

• To measure the reduction in total procedure use (and the invasive procedure sub-group) count between control and test arms when Cxbladder is used in the evaluation. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To evaluate the increase in utility as defined by the reduction in total procedures (and the invasive procedures subgroup) count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis.
• To measure the proportion of subjects who were ruled out on the test arm when Cxbladder is used in the evaluation [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To quantify the 'rule-out' percentage (proportion ruled out from further evaluation by the physician) when Cxbladder is used in the evaluation.
• To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  To quantify the false negative rate (the percentage of the negative fraction incorrectly diagnosed) associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC
• Proportion of subjects (and sub-groups within test and control arms) with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients referred for evaluation of hematuria.
• To compare the total score of the anxiety and pain level associated with cystoscopy vs Cxbladder by using Patient Result Outcome questionnaire and WIWI(was it worthy it) [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  Subjects will have Patient Reported Outcomes at enrollment for all subjects on the test arm to set a baseline and post cystoscopy for all subjects on the test arm. For all of the PROMIS short forms we will report PROMIS T-scores. For both measures, the raw score will be converted to a T-score which rescales the raw score into a standardized score that ranges from 0 to 100 with a mean of 50 and a standard deviation of 10. Anxiety level has four questions with five scales of answers. Pain level has three questions with five scales of answers. WIWI has 6 questions on the three scales to describe answers.
• Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
  Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively. Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.

• Hematuria
• Urothelial Carcinoma

• Active Comparator: Test, subjects categorised as "low risk" or "Not low risk"
  A clinical risk factor nomogram risk classification will be used in this study. The nomogram categorizes subjects as either "low risk" or "not low risk" categories. "Low risk" subjects satisfy all conditions and "not low risk" satisfies at least one of the conditions.The Cxbladder Triage test result will be provided to physicians for all "low risk" subjects on the test arm. If a "low risk" subject has a Cxbladder Triage negative test result then the indication is to rule out the subject without further assessment. The decision to rule-out or further evaluate is solely that of the physician and subject. If the "low risk" subjects are not Cxbladder Triage negative then a Cxbladder Detect test result will also be provided. The indication is further evaluation as per standard of care. Subjects categorised as "not low risk" will be evaluated as per standard of care. Note that Cxbladder test results will be available for eventual analysis for these subjects.
  Intervention: Diagnostic Test: Cxbladder
• No Intervention: Control
  Subjects on the control arm will be on standard of care. Trial nomogram clinical risk factor categorization for control arm subjects will not be provided to the physician (but appropriate information will be collected on the CRF to enable sub-group analysis) No Cxbladder test results will be provided for control arm subjects. Note that Cxbladder test results will be available for eventual analysis for these subjects.

Inclusion Criteria :

1. Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
2. Able to provide a voided urine sample of the required minimum volume
3. Able to give written consent
4. Able and willing to comply with study requirements
5. Aged 18 years or older

Exclusion Criteria

1. Prior history of bladder malignancy, prostate or renal cell carcinoma
2. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
3. History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
4. Previous alkylating based chemotherapy
5. Pregnancy