FDA Breakthrough Device using Optical Spectroscopy was Found to Significantly Increase Physicians’ Detection of Skin Cancer

MIAMI–(BUSINESS WIRE)–DermaSensor Inc., the pioneer of the first point-and-click skin cancer detection device for primary care physicians, announces the publication of a new study¹ in the Journal of Primary Care and Community Health. This study, authored by medical leaders including Laura Korb Ferris, MD, and Todd Thames, MD, evaluated the impact of the DermaSensor device on PCPs’ skin cancer diagnosis and management. The study involved 57 U.S. board-certified PCPs who collectively completed over 5,000 assessments of skin lesions.¹

This recently published utility study follows a recently published preceding clinical study, which was conducted to determine the standalone performance of the device and was recently published by the American Academy of Dermatology². The device, which employs elastic scattering spectroscopy (ESS) and machine learning, was found in this utility study to significantly improve PCPs’ referral of malignant lesions to dermatologists. This companion study was conducted to provide clinical evidence for European regulatory authorities as well as initial effectiveness evidence for the FDA. The device has been under review by the FDA since early 2023; it is not currently available for sale in the United States.

Skin cancer remains the most prevalent type of cancer in the United States, posing a significant challenge for PCPs who often encounter patients with suspicious skin lesions. DermaSensor’s innovative handheld device, developed as an objective tool for the primary care setting, aims to address this challenge by providing immediate information on lesions’ risk level through its optical spectroscopy and machine learning technology.

The key findings of this study were that the PCPs’ referral of skin cancer significantly increased from 81% to 94% (p-value = 0.0009), thereby decreasing PCPs’ missed skin cancers by 68% (from 19% to 6%). The specificity also decreased from 36% to 31%, which was a non-significant decrease (p-value = 0.3558). Similarly, the PCPs’ diagnostic sensitivity significantly increased and their diagnostic specificity non-significantly decreased. The device was also found to significantly improve PCPs’ confidence in their clinical decisions.

Laura Korb Ferris, MD, senior author of this paper and Professor of Dermatology and Director of the University of Pittsburgh Department of Dermatology Clinical Trials Unit, was optimistic about the study findings: “Our study indicates that DermaSensor’s ESS device has the potential to enhance the detection of skin malignancies in the primary care setting. This technology not only improved PCPs’ sensitivity for lesion referral but also significantly increased their confidence, both of which are particularly important for non-specialists.”

Cody Simmons, CEO of DermaSensor, commented on the groundbreaking implications of the study: “The findings of this study reinforce our commitment to providing innovative solutions for the detection of skin cancer. The findings from this study suggest that the device could greatly benefit PCPs and their patients. It is an honor that this journal and group of authors have published these study findings, including Dr. Ferris, who is a world-renowned thought leader in the field of non-invasive skin cancer detection tools.”

The ESS device utilizes advanced spectroscopy and machine learning to evaluate lesions risk of being malignant, providing physicians with valuable information that will augment their clinical assessment and management decisions. The device’s AI algorithm was trained with over 10,000 spectral recordings from a diverse set of skin lesions.²

About DermaSensor

DermaSensor Inc. is a health technology company designing non-invasive tools to better equip primary care providers for skin cancer detection. The DermaSensor device is an affordable, handheld tool that uses spectroscopy and algorithms to evaluate skin lesions for potential cancer in a matter of seconds. DermaSensor’s mission is to provide broad access to effective skin cancer checks. The DermaSensor device is currently CE Marked and is available for sale in Australia. The DermaSensor device’s FDA submission is currently under review; it is not available for sale in the United States.

References

1. Jaklitsch E, Thames T, de Campos Silva T, Coll P, Oliviero M, Ferris LK. Clinical Utility of an AI-powered, Handheld Elastic Scattering Spectroscopy Device on the Diagnosis and Management of Skin Cancer by Primary Care Physicians. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231205979. doi: 10.1177/21501319231205979. PMID: 37933569; PMCID: PMC10631325.

2. Manolakos D, Patrick G, Geisse JK, Rabinovitz H, Buchanan K, Hoang P, Rodriguez-Diaz E, Bigio IJ, Cognetta AB, Use of an Elastic-Scattering Spectroscopy and Artificial Intelligence Device in the Assessment of Lesions Suggestive of Skin Cancer: A Comparative Effectiveness Study, JAAD International (2023), doi: https://doi.org/10.1016/j.jdin.2023.08.019.

Contacts

Larry C. Anderson

Chief Commercial Officer DermaSensor, Inc.

(213)219-5862

larry.anderson@dermasensor.com