Hematuria and Recurrence
Hematuria Clinical Study
Predictive Biosciences conducted a multicenter U.S. trial of 748 patients presenting with hematuria (no history of bladder cancer). The majority of these sites were community-based urology practices.
Patient Demographics:
- 748 patients with gross or microscopic hematuria.
- 60% men / 40% women
- 60% smokers
Results:
|
Cancer: 58 cancers (biopsy confirmed) |
Non-cancer: 690 cystoscopy negative |
|---|---|
| Specificity 99.9% | Sensitivity 87.9% |
| PPV 95.2% | NPV 98.2% |
| Rule-in cancer in >34% of patients | Rule-out cancer in >56% of patients |
Learn more about the CertNDx Bladder Cancer Assay for Hematuria Assessment.
Recurrence Clinical Study
A second multicenter U.S. trial was conduct on 733 patients with a prior history of bladder cancer who were undergoing routine surveillance. The majority of these sites were community-based urology practices.
Patient Demographics:
- 733 patients with a prior history of bladder cancer
- 77% men / 23% women
- 77% smokers
Results:
|
Cancer: 63 cancers (biopsy confirmed) |
Non-cancer: 670 cystoscopy negative |
|---|---|
| Specificity 95.5% | Sensitivity 90.5% |
| PPV 38.8% | NPV 97.5% |
| Identify >30% of bladder cancer cases | Identify >34% of cancer-free cases |
Learn more about the CertNDx Bladder Cancer Assay for Recurrence Monitoring.
