Table 5.
Observed sensitivity and specificity for the dermoscopic, investigational site's histopathology evaluations, as well as the Nevisense result grouped according to the study's histopathological gold standard (HGS). The results are derived from the cohort of eligible and evaluable lesions that had sufficient image quality to render a dermoscopic evaluation
| Type | Seven-point | Seven-point weighted | ABCD dermoscopy < 5·45 | ABCD dermoscopy < 4·75 | Malignancy gradinga | Investigational site's histopathology | Nevisense |
|---|---|---|---|---|---|---|---|
| Melanoma sensitivity | 49·2 | 60·9 | 47·1 | 54·2 | 70·6 | 84·5 | 97·1 |
| pTis | 28·7 | 43·6 | 28·7 | 37·6 | 55·4 | 73·3 | 94·1 |
| pT1a | 57·1 | 65·5 | 51·2 | 57·1 | 75·0 | 89·3 | 98·8 |
| pT1b | 76·5 | 76·5 | 76·5 | 82·4 | 88·2 | 100·0 | 100·0 |
| pT2a | 63·6 | 86·4 | 72·7 | 72·7 | 90·9 | 95·5 | 100·0 |
| pT2b | 88·9 | 100·0 | 88·9 | 88·9 | 100·0 | 100·0 | 100·0 |
| pT3a | 100·0 | 100·0 | 100·0 | 100·0 | 100·0 | 100·0 | 100·0 |
| pT3b | 100·0 | 100·0 | 66·7 | 100·0 | 100·0 | 100·0 | 100·0 |
| pT4a | 100·0 | 100·0 | 0 | 100·0 | 100·0 | 100·0 | 100·0 |
| Severe dysplasia sensitivityb | 12·1 | 24·8 | 12·8 | 20·8 | 38·3 | NA | 83·9 |
| Overall specificity | 94·2 | 89·2 | 94·0 | 90·1 | 81·4 | 98·0 | 35·8 |
All values given as a percentage. NA, not applicable.
a
Overall malignancy grading as determined by the visual classification board with a fixed cut-off at 4.
b
Severe cytologic atypia or architectural disorder where diagnosed as severe dysplasia.