Sensitivity and specificity values were 95% and 85%, respectively, and 100% and 93% for invasive melanomas
Results from a prospective, multicentre, clinical trial published today in the peer-reviewed British Journal of Dermatology link to article showed that AI helps significantly improve melanoma detection rates.
The trial, conducted in 37 Swedish primary care facilities was designed to evaluate Dermalyser a smartphone-based diagnostic decision support system empowered by advanced artificial intelligence (AI).
228 patients examined in primary care and exhibiting skin lesions raising concern for melanomas by the doctor, also underwent an additional assessment using a smartphone equipped with a dermatoscope mounted in front of the camera (Dermalyser). Among 253 lesions of concern identified, 21 proved to be melanomas, with 11 invasive melanomas and 10 melanomas in situ (precancerous melanocytic lesions).
Area Under the Receiver Operating Characteristic (AUROC) curve was generated to evaluate Dermalyser’s accuracy in identifying melanomas. For invasive melanomas AUROC was 0.965–0.997, corresponding to a maximum sensitivity and specificity of 100% and 92.6%, respectively. Also including melanomas in situ, AUROC was 0.960 with maximum sensitivity and specificity of 95.2% and 84.5%, respectively.
Magnus Falk, Associate Professor in General Practice and Principal Investigator, Department of Health, Medicine and Caring Sciences, Linköping University, comments: “The clinical decision support tool evaluated in this investigation showed high diagnostic accuracy when used prospectively on primary care patients, which could add significant clinical value for PCPs in assessing skin lesions to detect melanoma. Additionally, the medical personnel involved in the trial were willing to put a high level of trust in Dermalyser, strongly indicating it can be easily worked into current clinical routines.”
Christoffer Ekström, CEO of AI Medical Technology adds: “We believe this trial has decisively proven that using AI can revolutionise melanoma diagnosis. This will save lives and also remove the anxiety and often devasting consequences of false results. The European market is our first priority for Dermalyser, but the recently approved AI-powered device for detecting skin cancer by the FDA has also established a clear regulatory pathway for us and we now accelerate our plans for entering the US market.”