Presented at the Society of Teachers of Family Medicine (STFM) 2023 annual meeting, the two FDA pivotal studies validated the performance and benefit of the hand-held, non-invasive, optical spectroscopy device in point-of-care skin lesion evaluation.
MIAMI, May 04,2023, Business Wire — DermaSensor Inc., in collaboration with leading medical institutions such as Mayo Clinic and the University of Connecticut School of Medicine, marked the commencement of Skin Cancer Awareness Month by presenting the successful validation and utility of the company’s novel Elastic Scattering Spectroscopy (ESS) device in assisting primary care physician’s (PCPs) detection of 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 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. 83.0%, 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 82.0% 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 18.0% 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.”— Dr. Daniel Siegel, a Clinical Professor of Dermatology at SUNY Downstate and the principal investigator for the clinical utility study
Dr. Siegel continued, “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.3,4,5 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,” said Cody Simmons, DermaSensor’s CEO. “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.”
- Skin Cancer Facts & Statistics. Skin Cancer Foundation. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/. Accessed April 25, 2023.
- 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.
- 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.
- 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.
- 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.