The device demonstrated an overall sensitivity of 97%.

DermaSensor, a handheld AI-powered spectroscopy device, works well at assessing skin lesions suggestive of skin cancer and should help primary care doctors improve their decision-making skills regarding appropriate referrals of skin cancer

The new study, which will be published in JAAD International, was conducted to provide clinical evidence for European regulatory authorities and initial effectiveness evidence for the U.S. Food and Drug Administration (FDA). The device has been under review by the FDA since early 2023 and is not currently available for sale in the United States.

For the study, patients with skin lesions suggestive of both melanoma and non-melanoma skin cancers underwent clinical evaluation by dermatologists and by the DermaSensor device,  Key statistical metrics, such as sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and Area Under the Curve (AUC), were used to assess performance.

The device demonstrated an overall sensitivity of 97.0% (n=169) for the study’s test dataset. When examining specific skin cancer types, subgroup sensitivity rates were 96.7% for melanoma (n=30), 97.0% for basal cell carcinoma (n=72), and 97.0% for squamous cell carcinoma (n=67). Importantly, the device’s sensitivity and overall accuracy were each within 1% of the sensitivity and accuracy of the dermatologists’ in-person clinical assessments when enrolling the lesions. The device exhibited a specificity of 22% for benign lesions biopsied by the dermatologists, and the device’s overall NPV was 90% and PPV was 58%. A PPV of 58% equates to a number needed to biopsy (NNB) of 1.7 for detecting one skin cancer. 

“This study shows that the DermaSensor device has high performance in detecting malignancies and should help primary care providers by improving their decision-making regarding appropriate referrals of skin cancer,” says study author Armand Cognetta, MD, Program Director and Professor at the Florida State University College of Medicine in Tallahassee.

“This study was a key early comparative effectiveness study showing that our device can bring dermatologist-level triage to primary care. We have completed eight clinical studies for review by regulatory bodies in the U.S. and Europe, and we hope to soon be the first-ever device on the U.S. market that provides primary care providers with an immediate, objective result for skin cancer,” adds Cody Simmons, co-founder and CEO of DermaSensor Inc. “While dermatoscopes are in widespread use by dermatologists and have been in dermatology clinical guidelines since 1989, only 8% of primary care providers currently use one given the significant training time required. We hope to soon have available our first-in-class device for America’s 300,000 primary care providers, and that its simple point-and-click method of use will result in widespread adoption.”