Table 1.
Diagnostic performance of Oncuria assay in identifying high-grade/low-grade and highstage/low-stage BC.
| Tumor Grade | Number of BC cases predicted by biomarker assay | AUC | Sensitivity (%) | Specificity (%) | NPV (%) | PPV (%) |
|---|---|---|---|---|---|---|
| Overall | 42/45* | 0.95 | 0.93 | 0.93 | 0.99 | 0.65 |
| Low-grade tumors | 8/9 | 0.94 | 0.89 | 0.93 | 1.00 | 0.26 |
| High-grade tumors | 34/36 | 0.95 | 0.94 | 0.93 | 1.00 | 0.60 |
| NMIBC | 25/27 | 0.93 | 0.93 | 0.93 | 0.99 | 0.52 |
| MIBC | 15/16 | 0.97 | 0.94 | 0.93 | 1.00 | 0.39 |
NMIBC = non-muscle-invasive bladder cancer, MIBC = muscle invasive bladder cancer, AUC = Area under ROC curve, NPV = negative predictive value, PPV = positive predictive value.
*
1 case was missing a single analyte and thus excluded.
N = 362 subjects presenting for bladder cancer evaluation. Instrumentation was Luminex 100/200 analyzer.