The  device uses spectroscopy and algorithms to evaluate skin lesions for potential cancer.

DermaSensor Inc.’s novel Elastic Scattering Spectroscopy (ESS) device can help primary care physician's spot skin cancers, according to two new studies presented at the Society of Teachers of Family Medicine 2023 annual meeting.

The DermaSensor device is currently CE Marked and is available for sale in Australia. The DermaSensor device’s FDA submission is pending review; it is not available for sale in the United States.

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. 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. 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," says Dr. Daniel Siegel, a Clinical Professor of Dermatology at SUNY Downstate and the principal investigator for the clinical utility study, in a news release. “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.” 

"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," adds 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."