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MIAMI, February 28, 2024 (BUSINESSWIRE)— DermaSensor Inc., a health technology company equipping physicians with a non-invasive device for use in the evaluation of suspicious skin lesions, announces the publication of strong results from a multi-center, prospective device validation study for melanoma detection. The study, titled “DERMaSensor Use in the ASSESSment of Skin Lesions Suggestive of Melanoma III (DERM-ASSESS III)”, was conducted across 8 United States and 2 Australian sites and was published in JAAD (Journal of the American Academy of Dermatology) International.1
The non-invasive, AI-powered device exhibited a sensitivity of 95.5% (95% CI, 84.5%-98.8%), showcasing its effectiveness in correctly identifying melanomas. In addition, the Negative Predictive Value (NPV) of 98.1% (95% CI, 91.8%-99.6%) indicates a high level of reliability for a negative device result of “Monitor”. For a positive device result of “Investigate Further”, a 1-10 score is also provided to indicate the degree of similarity to malignant lesions. The study found that the likelihood of melanoma for these positive results ranged from 10.3% for low scores (i.e., 1-3) to 47.4% for high scores (i.e., 8-10).
In discussing the implications of the study, the paper’s lead author and study Principal Investigator Dr. Rebecca Hartman describes the importance of these study results, stating, “The high device sensitivity and NPV suggest a potential role for the device to rule out melanoma, which could reduce unnecessary dermatology referrals. This can result in improved access to dermatology care for those in need, which is critical given dermatology wait times across the country.” Dr. Hartman is an Assistant Professor of Dermatology at Brigham and Women’s Hospital and Harvard Medical School in Boston and Chief of the Dermatology Section at VA Boston Healthcare System.
The overall diagnostic accuracy (as determined by Area Under the Curve) of the device was 0.758, which was similar to that of the in-person expert dermatologist investigators of 0.747 (p = 0.829). In addition to the device correctly detecting 95.5% of melanoma, the device also correctly identified as benign 32.5% (95% CI, 27.2%-38.3%) of benign lesions that were biopsied by the study dermatologists as suspicious for melanoma. This underscores the device’s practical utility in discerning benign lesions, while still effectively detecting melanoma.
This study was conducted by high-volume melanoma dermatology centers in the US and Australia. so device results may differ in primary care where the device is indicated for use. The device provides a helpful, point-of-care diagnostic assessment for non-dermatologist physicians given its similar performance to the expert dermatologists in this setting and its simple, non-invasive use. This study was one of six clinical studies that were reviewed by the FDA and were the basis for the FDA’s clearance of the DermaSensor device in January 2024.
“One in five Americans will develop skin cancer by the age of 70 and more than two people die of skin cancer in the U.S. every hour,” said Dr. Gary Slatko, Chief Medical Officer at DermaSensor, commented on the study’s findings and implications for patient care, stating, “The device’s high sensitivity and NPV, coupled with its accuracy being similar to that of the impressive dermatologists in this study, affirm the effectiveness of our FDA-cleared device. We’re eager to deliver this transformative, easy-to-use technology into the hands of tens of thousands of healthcare providers to improve their performance and confidence to the benefit of patients nationwide. This automated, objective device can help in the fight against skin cancer, and the DermaSensor team is dedicated to making a meaningful contribution to its detection and prevention.”
Conflicts of Interest: This study was a company-sponsored study. The institution of Dr. Rebecca Hartman, Dana-Farber Cancer Institute, received funding for the clinical research for this study. Dr. Gary Slatko is an employee of DermaSensor Inc.
References: 1. Hartman RI, Trepanowski N, Chang MS, Tepedino K, Gianacas C, McNiff JM, Fung M, Braghiroli NF, Grant-Kels JM, Multicenter Prospective Blinded Melanoma Detection Study with a Handheld Elastic Scattering Spectroscopy Device, JAAD International (2023), doi: https:// doi.org/10.1016/j.jdin.2023.10.011.
