New Swedish clinical study published in the British Journal of Dermatology demonstrates superiority of AI-algorithm guided melanoma diagnosis
Dermalyser AI-driven support tool achieved remarkable sensitivity and specificity values of 95% and 85%, respectively, with these figures increasing to 100% and 93% for invasive melanomas.
Stockholm, Sweden, March 6, 2024. Results from a prospective, multicentre, clinical trial published today in the peer-reviewed British Journal of Dermatology showed that AI helps significantly improve melanoma detection rates.
The trial was designed to evaluate Dermalyser, a smartphone-based diagnostic decision support system empowered by advanced artificial intelligence (AI) and was conducted in 37 Swedish primary care facilities.
Procedure: 228 patients with skin lesions of concern when examined by their primary care physician, were recruited to participate. In case the physician was not fully sure that the lesion wasn’t a melanoma, the lesion was included and underwent the following diagnostic procedures:
A smartphone with a dermatoscope mounted in front of the camera was used to photograph skin lesions of concern. Within seconds, the built-in Dermalyser app produced an output – either indicating or contraindicating the presence of melanoma.
Regardless of Dermalyser’s output, all lesions examined in step 1 underwent further diagnostic investigation, either by surgical excision, or by referral to a dermatologist, to establish whether it was a melanoma or not. Lesion diagnoses were collected from the patients’ medical records and compared to Dermalyser’s output. Results: In total, 253 lesions of concern were identified in 228 patients. 21 proved to be melanomas, with 11 invasive melanomas and 10 melanoma in situ (precancerous melanocytic lesions).
To gauge Dermalyser’s accuracy in identifying melanomas, an Area Under the Receiver Operating Characteristic (AUROC) curve was generated, which for invasive melanomas had a value of 0.988 (0.965–0.997), corresponding to a maximum sensitivity and specificity of 100% and 92.6%, respectively. When also including melanomas in situ, the AUROC was 0.960, corresponding to a 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, a further clear impression from this trial is that 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.”
Sam Polesie, Adjunct Senior Lecturer, Department of Dermatology and Venereology, Sahlgrenska University Hospital, Gothenburg comments: “In recent years, the precision of AI in analysing dermatoscopic images to identify melanoma has reached or even surpassed experienced dermatologists. Yet, only a limited number of studies have tested these systems under real-world conditions. This study is notable for its execution in a real clinical setting, which makes its findings especially compelling. I am enthusiastic about the results and anticipate being a part of a future where systems like Dermalyser, supported by rigorous research and in full compliance with all necessary regulations, are integrated into routine healthcare. This includes both general dermatology and specifically the diagnosis of skin cancer. The fundamental goal is, of course, to improve clinical decision-making processes for more precise and, therefore, safer diagnoses.
Christoffer Ekström, CEO of AI Medical Technology adds: “Just as in analysing mammograms for diagnosing breast cancer or neuroimaging for Alzheimer’s disease, 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 still 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 are now accelerating our plans for entering the US market.”
For more information, please contact: Christoffer Ekström, CEO AI Medical Technology Email: christoffer@aimedtech.com Cell phone: +46704 02 71 01
Notes to editors The published article: Panagiotis Papachristou, et.al. (2024), Evaluation of an artificial intelligence-based decision support for the detection of cutaneous melanoma in primary care: a prospective real-life clinical trial, British Journal of Dermatology, 00:1–9, https://doi.org/10.1093/bjd/ljae021
Melanoma skin cancer According to Cancer Today, one person dies of skin cancer every four minutes. In 2020, the incidence of new melanoma cases was over 320,000 worldwide, with this figure expected to reach almost 500,000 by 2040. Further statistics show that as many as 99% of the cases are curable if they are diagnosed and treated early enough, underscoring the importance of not only continuous self-examination, but also early and accurate diagnostic tools. https://gco.iarc.fr/today/home
About Dermalyser Dermalyser is a mobile application powered by artificial intelligence (AI) that can provide diagnostic decision support for medical professionals in clinical settings. Dermalyser enables fast and direct diagnostic decision support with high accuracy when diagnosing skin cancer such as melanoma of the skin. The application is used with a dermatoscope mounted in front of the smartphone camera. The Medical professional takes an image of the patients’ skin lesion and, within a few seconds, receives a diagnosis from the AI in return. Using Dermalyser enables clinicians to miss fewer cancers and helps ensure that fewer patients undergo unnecessary excisions of benign skin lesions, increasing the efficiency of healthcare systems while also saving lives.
About AI Medical Technology AI Medical Technology is a company operating in the interdisciplinary fields of data science, software development, and medicine. The company is dedicated to developing AI-powered diagnostic solutions that enable frontline healthcare practitioners to make easier, faster and more reliable diagnoses for their patients.The team is now focused on bringing the first product, Dermalyser, a clinically validated decision support tool for diagnosing skin cancer, through clinical trials and to the market. For more information see www.aimedtech.com and https://www.linkedin.com/company/aimedicaltechnology/
**About British Journal of Dermatology ** The British Journal of Dermatology (BJD) is a top-ranked international dermatology journal, publishing the highest-quality research to advance the understanding and management of skin disease to improve patient outcomes. The BJD is one of the journals of the British Association of Dermatologists, the professional membership body for dermatologists in the UK. Oxford University Press (OUP) is BAD's publishing partner. OUP publishes over 500 academic and research journals covering a broad range of subject areas, two-thirds of which are published in collaboration with learned societies and other international organizations. OUP has been publishing journals for more than a century and, as the world’s largest university press, has more than 500 years of publishing expertise. For more information, visit academic.oup.com.