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
The classifier in Nevisense, used for classifying the lesion, has been developed in several iterations with measurement data collected during training studies with nearly 2,000 patients at 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.
In 2018, an update to the method was made, where the major change was that a reference measurement is not needed for each lesion tested. Previously two sites (reference and lesion) had to be measured, but from 2018, only the lesion has to be measured. The innovation that made this possible is that skin features previously taken from the reference measurement is now extracted from the lesion. This change made the measurement process more streamlined and improved the accuracy of the EIS method.
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 with the updated method on pivotal study data show an observed 97.0% sensitivity for malignant melanoma in the target population. In addition, Nevisense achieved an observed specificity of 37.5% on lesions with clinical suspicion of malignant melanoma, representing the potential reduction of unnecessary excisions
Post Pivotal Study: Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions
In a study lead by Dr. Scott Menzies, a total of 118 patients was enrolled at two centers in Australia. The study aimed to evaluate the influence of adding an Nevisense EIS measurement at baseline to suspicious melanocytic lesions undergoing routine short-term digital dermoscopy imaging (SDDI) using a protocol with a pre-determined EIS score. The conclusion was that adding Nevisense in compliance with the protocol archived good diagnostic accuracy while avoiding the need of follow up by 47%.