Nevisense has been indicated for melanoma detection since 2014 with more than 100.000 examinations performed.
Nevisense is now also indicated for Keratinocyte cancers based on data from several clinical studies.
In most cases benign lesions and keratinocyte cancers can be confidently identified.
For more challenging cases, such as borderline and non-typical lesions, additional information may be required. The Nevisense evaluation is used for risk assessment, together with patient history and visual examination.
Nevisense provides an objective analysis indicating the probability of malignancy based on extensive clinical study data. The physician combines the visual evaluation with the added Nevisense analysis to make a clinical decision.
Nevisense score for keratinocyte cancer, showing a positive score of 5 indicating somewhat increased risk for malignancy.
Nevisense is safe and easy to use.
To evaluate the lesion’s degree of atypia, measurements are performed on the lesion after the skin is prepared by moistening with physiological saline solution. The procedure is easy, and the results are displayed within seconds.
Three controlled clinical studies that were used to evaluate the clinical performance of Nevisense on keratinocyte cancer included in total 123 Basal Cell Carcinoma (BCC), 29 Squamos Cell Carcinoma (SCC), 23 Actinic Keratosis (AK) and 1988 benign lesions. The result from these studies provided an observed clinical accuracy for keratinocyte cancers as below:
- Sensitivity: 100% [98.1% one sided 95% confidence interval]
- Specificity: 53,8% [51.6%, 56.0% two sided 95% confidence interval]
- Negative Predictive Value (NPV): 100%
- Positive predictive value (PPV): 14,7%
In the boxplot above, the KC lesions have an average EIS score of 8, whereas Melanoma has an average score of 7, and atypical lesions (including benign lesions and mild-moderate dysplastic nevus) has an average EIS score of 4.