DermaSensor’s Elastic Scattering Spectroscopy (ESS) device has demonstrated a 96% sensitivity rate in detecting skin cancer, according to two newly published studies involving 1,005 patients and 1,579 lesions.
Conducted in collaboration with Mayo Clinic, Yale University, and others, the studies validate the device’s use in primary care. The multicentre validation study confirmed 224 cases of skin cancer, including melanomas, basal cell carcinomas, and squamous cell carcinomas, across 22 primary care sites.
The ESS device’s sensitivity surpasses the 90% benchmark based on dermatologists’ sensitivity, meeting the FDA’s minimum requirement for melanoma. Its negative predictive value (NPV) is 97%, indicating a high likelihood of benign lesions when results are negative. Positive predictive value (PPV) varies, ranging from 6% for a score of 1 to 61% for a score of 10.
In a related clinical utility study with 108 physicians, the ESS device improved the accuracy of skin cancer referrals and management. Primary care physicians (PCPs) correctly referred 91.4% of malignant lesions with the device’s aid, compared to 82.0% without it. This marks a 50% reduction in missed cancer referrals, dropping from 18.0% to 8.6%.
Skin cancer is the most prevalent cancer worldwide, with annual cases exceeding those of all other cancers combined, said DermaSensor. Despite the potential for prevention through sun protection and early detection, delayed diagnosis continues to contribute to preventable mortality, morbidity, and increased healthcare costs.
DermaSensor co-founder and CEO Cody Simmons said: “These two FDA pivotal studies – the main clinical studies of the six submitted to FDA – highlight the strong performance and benefits of our device, which were instrumental in DermaSensor becoming the first FDA-authorised tool in the US that provides anyone with any kind of objective risk assessment for melanoma, BCC and SCC.
“Since receiving FDA De Novo clearance of this FDA Breakthrough Device last year, there are already hundreds of diverse doctors using our devices, and we are working to quickly scale device adoption so that our device can benefit many of the millions of patients that are diagnosed with skin cancer each year.”
