Clinical Evidence

Nevisense has undergone extensive evaluation for more than a decade, from development and proof of principle to algorithm training and clinical studies. To date, more than 4,000 patients and healthy volunteers have undergone measurements using Nevisense, including analysis of 2,416 lesions in the pivotal study, published in the British Journal of Dermatology.

From clinical development to pivotal study

Beginning in 1998, a Nevisense prototype underwent 6 years of initial studies proving the functionality of the SciBase method. Over the course of 7 studies involving 1,200 patients, the method’s success motivated a progression to the next phase: algorithm training for a classifier for malignant melanoma.

The largest prospective pivotal study in melanoma detection

To develop the classifier system, the algorithm was trained on nearly 2,000 patients in more than 19 sites in Europe. Two studies and five years later, the final Nevisense product was prepared for trials in the largest prospective pivotal study ever conducted in melanoma detection.

The pivotal study: process and verification

The pivotal study was performed with the objective to provide scientific evidence of the accuracy of the SciBase system in detecting malignant melanoma. It was also designed to provide scientific evidence of the method’s accuracy and safety as the basis for regulatory approval.

The study, an international, multicenter, prospective clinical trial, was conducted at both private and academic dermatological centers. Prior to initiation, the study was approved by national and local ethics committees/institutional boards and carried out in accordance with the international conference of harmonization of good clinical practice (ICH-GCP) and ISO 14155:1-2.

The study was conducted in both Europe and the US with 22 participating clinics in the UK, Germany, Sweden, Hungary, Austria, Spain and the US.

A total of 2,416 lesions and 1,951 patients were included in the study.

The pivotal study: results

Results of the pivotal study showed 97% sensitivity on malignant melanoma for the target population. In addition, the SciBase method achieved a specificity of 34% on lesions with clinical suspicion of malignant melanoma, representing the potential reduction of unnecessary excisions.