FDA Studies Validate Performance, Benefits of DermaSensor’s Skin Cancer Detection Device

DermaSensor Inc., in collaboration with leading medical institutions such as Mayo Clinic and the University of Connecticut School of Medicine, has released clinical data showing the successful validation and utility of the company’s Elastic Scattering Spectroscopy (ESS) device in detecting skin cancers. Of the two studies presented, one demonstrated the standalone performance of the hand-held, non-invasive device, and the other evaluated the impact of the device on primary care physicians’ (PCPs’) management of skin cancer.
 
In the clinical validation study, a total of 1,005 patients were enrolled across 22 primary care study centers, and 1,579 lesions were evaluated. Dermatopathology evaluation confirmed 224 high-risk lesions, including melanomas, basal cell carcinomas, and squamous cell carcinomas. The ESS device achieved device sensitivity superior to that of the PCPs (95.5% vs. 83%, p-value <0.0001). The companion clinical utility reader study was conducted with 108 PCPs and successfully demonstrated that PCPs’ use of the device result improved their detection of skin cancer (p-value = 0.003). When unaided by the device the PCPs only correctly referred 82% of cancerous lesions, whereas when the PCPs were equipped with the device result they correctly referred 91.4% of skin cancers. Accordingly, the physicians incorrectly did not refer 18% of skin cancers with their standard of care alone, but that number was halved to just 8.6% when aided by the device. Physician referrals of benign lesions were observed to increase when aided by the device result.
 
“As skin cancer rates continue to rise, the need for accurate and efficient skin cancer detection in primary care is increasingly important. These studies have shown the ESS device benefits physicians, and it is also a non-invasive, easy-to-use solution for instantaneously evaluating suspicious lesions,” said Dr. Daniel Siegel, a clinical professor of Dermatology at SUNY Downstate and the principal investigator for the clinical utility study. “Effective tools for skin cancer detection and management could lead to earlier diagnosis, better outcomes, and reduced healthcare costs for patients and the healthcare system as a whole.” In addition to Dr. Siegel’s academic position, he serves those who served at the Brooklyn VA and is a former president of the American Academy of Dermatology.
 
Skin cancer is the most common type of cancer, with more cases diagnosed each year than all other types of cancer combined.^1,2 Despite the high incidence of skin cancer, many cases are preventable through simple measures such as using sunscreen and protective clothing, seeking shade during peak UV hours, and avoiding tanning beds.^3-5 Early detection and prompt treatment are critical for improving outcomes and reducing the burden of the disease.^1,3
 
“These two pivotal studies, which are two of four studies currently under review by FDA, have shown that our FDA Breakthrough device significantly improves skin cancer detection by primary care physicians,” DermaSensor CEO Cody Simmons said. “The results of both studies provide clear evidence that our ESS device is a valuable tool in point-of-care skin lesion evaluation with the ability to aid PCPs in identifying skin cancer for referral.”
 
DermaSensor Inc. designs non-invasive tools to better equip primary care providers for skin cancer detection. The DermaSensor device is a 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 U.S. Food and Drug Administration submission is pending review; it is not available for sale in the United States.
 
References
¹ Skin Cancer Facts & Statistics. Skin Cancer Foundation. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/. Accessed April 25, 2023.
² Cancer Facts and Figures 2023. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cancer-facts-and-figures.pdf. Accessed April 25, 2023.
³ Koh HK, Geller AC, Miller DR, et al. Prevention and early detection strategies for melanoma and skin cancer: Current status. Arch Dermatol 1996; 132(4):436-442.
⁴ Green A, Williams G, Neale R, et al. Daily sunscreen application and betacarotene supplementation in prevention of basal-cell and squamous-cell carcinomas of the skin: a randomized controlled trial. The Lancet 1999; 354(9180):723-729.
⁵ Ferrucci LM, Cartmel B, Molinaro AM, et al. Indoor tanning and risk of early-onset basal cell carcinoma. J Am Acad Dermatol 2012 Oct; 67(4):552-62.