TABLE 1.
MADR Assay Performance for the Derivation Population
| Biomarker | Negative assay criteria | NPV (%) | Sensitivity (% [range]) | POE (% [range]) |
|---|---|---|---|---|
| TWIST1 | <139 K | ND | 84 (71-94) | 82 (76-86) |
| NID2 | <680 K | ND | 33 (20-48) | 100 (99-100) |
| MMP-2 | <1.100 ng/mL | ND | 35 (22-51) | 74 (68-79) |
| FGFR3 | Negative | ND | 10 (3-23) | 99 (97-100) |
| All 4 biomarkers | 99.5 | 94 (83-99) | 65 (58-71) |
| Biomarker | PPV (%) | Specificity (% [range]) | POE (% [range]) | |
|---|---|---|---|---|
| FGFR3 | Positive | 71 | 99 (97-100) | 10 (3-23) |
MADR = multianalyte diagnostic readout; MMP-2 = matrix metalloproteinase 2; ND = not determined; NPV = negative predictive value; PPV = positive predictive value; POE = power of exclusion; POI = power of inclusion.