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FDA Cleared

DermaSensor Study Results For Skin Cancer Detection Device Performance Across Skin Tones Of Over 1,000 Patients

Presented at the 2023 American Academy of Dermatology Innovation Academy, the findings demonstrate the potential for DermaSensor’s device to help detect skin cancer across a range of skin types

MIAMI, August 10, 2023, Business Wire — DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for evaluating suspicious skin lesions, presented today promising results from a sub-analysis of the DERM-SUCCESS study.1 The analysis focused on the performance of DermaSensor’s handheld Elastic Scattering Spectroscopy (ESS) device in detecting skin cancer in patients across different Fitzpatrick skin types, a skin tone scale developed to classify skin coloring and response to ultraviolet (UV) radiation.2 In the study, DermaSensor’s ESS device demonstrated high sensitivity of 96% in detecting all skin cancer types when compared to the gold standard of histopathologic examination, with similar sensitivity and specificity across Fitzpatrick skin type subgroups.

“The findings of this sub-analysis are highly encouraging as they suggest that DermaSensor’s ESS device performance is not significantly impacted by underlying melanin content and can be a valuable tool in detecting skin cancer across different skin types, including patients with skin of color.”

— Dr. David J. Leffell, Professor of Dermatology, Plastic Surgery and Otolaryngology and Chief of the Dermatologic Surgery Program at the Yale School of Medicine. Dr. Leffell serves on the Scientific Advisory Board of DermaSensor

In the sub-analysis, patients were divided into two groups based on their Fitzpatrick skin types (FST): FST I-III and FST IV-VI, which are consistent with previous studies defining skin of color.34 Of the 1,005 patients enrolled in the study, 729 (72%) belonged to the FST I-III group, and 276 (28%) were in the FST IV-VI group. Forty-eight skin cancers were detected in subjects with Fitzpatrick skin type IV-VI. Importantly, there was minimal variation in device sensitivity, specificity, and Area under the Receiver Operating Characteristic Curve (AUROC) when comparing patients in the two FST subgroups to each other and to overall study results. The device sensitivity was similar between FST I-III and IV-VI, 96% and 92%, respectively, and AUROC was also similar with results of 0.779 for FST I-III and 0.764 for FST IV-VI.

“Our mission at DermaSensor has always been to provide access to tools to aid in skin cancer evaluations”, said Cody Simmons, CEO of DermaSensor. “The results from the DERM-SUCCESS study suggest that our ESS technology performs comparably regardless of skin type, which could improve providers’ ability to assess lesions on all patients and thus increase equitable access to effective skin cancer exams.”

References:

  1. Merry SP, et al. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial. JCAD 2023 April: 16(4 Suppl): s16.
  2. Bradford PT. Skin cancer in skin of color. Dermatol Nurs. 2009;21(4):170-178.
  3. Taylor SC, Cook-Bolden F. Defining skin of color. Cutis. 2002;69(6):435-437.
  4. Lopes FCPS, et al, Adamson AS. UV Exposure and the Risk of Cutaneous Melanoma in Skin of Color: A Systematic Review. JAMA Dermatol. 2021;157(2):213-219.

About DermaSensor

DermaSensor Inc. is a Miami-based connected medical device company that seeks to enable healthcare professionals to efficiently check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device concept is for an affordable handheld tool that uses artificial intelligence and spectroscopy to evaluate skin lesions for potential cancer in a matter of seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and to save lives. 

To speak to a representative of DermaSensor please contact press@dermasensor.com

DermaSensor Study Results For Skin Cancer Detection Device Performance Across Skin Tones Of Over 1,000 Patients

DermaSensor Study Results For Skin Cancer Detection Device Performance Across Skin Tones Of Over 1,000 Patients