CAC questions

We understand that there are other intended uses for urinary biomarkers. However, we are focusing on their use in the diagnostic setting for bladder cancer, prior to cancer identification and treatment. The use of these types of tests in the monitoring or surveillance setting will be addressed separately.

1. How would you select patients that would be appropriate for urinary biomarker testing in lieu of cystoscopy?
2. What percentage of patients that are recommended to get a cystoscopy per guidelines ultimately undergo cystoscopy? Are there any barriers and what are they?
3. What evidence is there on the differences between performing biomarker testing on specimens obtained through direct sampling of cells/tissue versus those obtained through urine collection?
4. What evidence is there on the performance of different biomarkers in the setting of hematuria: proteins vs. DNA vs. RNA?
5. How accurate would a test need to be to provide sufficient confidence in decision making to forgo a cystoscopy?
        a. What was the prevalence of bladder cancer in patient populations used to validate the various biomarker assays?
        b. What is the optimal sensitivity and specificity?
        c .What is the optimal PPV and NPV?
        d. What are the risks of false positives/negatives?
        e. What is the gold standard comparator?
6. How do these tests differentiate analytes from cells originating in the bladder vs. those from other tissues such as prostate or kidney?
7. What evidence is there comparing biomarker testing to nomograms/clinical factors only?
8. What outcomes have been published in the literature on patients with microhematuria who chose urinary biomarker testing over cystoscopy?
9. Have studies determined the percentage of patients with bladder cancer that may be missed using biomarkers only and if so, how long is the delay in diagnosis and are there any adverse outcomes?
10. If a biomarker test is performed and is negative and cystoscopy is not performed, should a repeat urine analysis be performed? If so, when? At what testing interval?
11. If a repeat UA demonstrates microhematuria after a negative biomarker test, should the biomarker test be repeated? If so, when? At what testing interval?
12. Under what circumstances would a patient need both cystoscopy and a urinary biomarker test?
13. What provider types should these tests be used by?
14. Do you use urine biomarker tests in your practice? If so, which ones and why? Do you forgo cystoscopy with a negative biomarker result?