Study Data Shows Benefits of DermaSensor’s Skin Cancer Detection Tech

DermaSensor Inc. is touting newly-published research indicating its device can help clinicians more accurately detect skin cancer while also effectively ruling out most benign lesions.
 
A study in the Journal of the American Board of Family Medicine (JABFM) assessed the accuracy and value of the DermaSensor device in helping primary care clinicians (PCC) differentiate between benign and malignant lesions.
 
“Detecting skin cancer early is crucial, as it can be treated successfully when found early,” said Nathalie Zeitouni, M.D., a nationally recognized Mohs and reconstructive surgeon at Medical Dermatology Specialists in Phoenix and one of the study authors. “In many parts of the country, a lack of access to dermatologists means that primary care physicians are often the first line of defense in evaluating skin cancers. This research shows that when patients are concerned about suspicious spots on the skin, DermaSensor accurately identifies benign lesions, which helps find malignant cases early. It also helps make sure that patients who really need to see a specialist get referred quickly, no matter how far away they live.”
 
This prospective study involved three PCCs in a rural setting who evaluated concerning skin lesions of 155 patients, resulting in the assessment of 178 lesions using the DermaSensor device compared to either biopsy or teledermatologist panel:¹

• The DermaSensor device had a 90% sensitivity and 60.7% specificity, meaningfully outperforming the clinicians’ standard of care management sensitivity of 40% while maintaining a similar specificity to the clinicians of 84.8%.
• For pigmented lesions, the device specificity was 76.9%, in high concordance with the teledermatologist panel, suggesting that the device can offer both patients and clinicians reassurance when evaluating lesions of concern to patients.
• The device achieved a 98.9% Negative Predictive Value (NPV), indicating its reliability in negative “Monitor” results correctly being diagnosed as benign. 

“This study further shows that DermaSensor represents a significant step forward in achieving our goal of making a meaningful difference in the fight against skin cancer,” DermaSensor Chief Medical Officer Gary Slatko, M.D., stated. “We designed the device to equip healthcare providers with a tool that helps quickly assess suspicious skin lesions so patients can get the best possible care.”
 
Skin cancer is the most common form of cancer in the United States, with one in five Americans developing it by the age of 70.² Wait times for dermatologist appointments can exceed five months.³ To help address this need, DermaSensor was developed to provide rapid, objective results for evaluating lesions suggestive of skin cancer, aiding in detection and treatment.
 
The JABFM study was part of the company’s European Union Medical Device Regulation (EU MDR) submission and was considered early effectiveness evidence for the U.S. Food and Drug Administration (FDA) submission and labeling. DermaSensor received FDA clearance in January 2024.
 
Miami-based DermaSensor Inc. is a health technology company designing non-invasive tools to better detect skin cancern. The DermaSensor device is a handheld tool that uses spectroscopy and algorithms to test skin lesions for cancer in seconds. 
 
References
¹ Tepedino M, et al. Elastic Scattering Spectroscopy on Patient-Selected Lesions Concerning for Skin Cancer. J Am Board Fam Med 2024;37:427–435. https://www.jabfm.org/content/37/3/427.
² The Skin Cancer Foundation. Skin Cancer Facts & Statistics. Last updated: February 2024. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/.
³ Merritt Hawkins. 2017 Survey of Physician Appointment Wait Times. https://www.aristamd.com/wp-content/uploads/2018/11/mha2017waittimesurveyPDF-1.pdf.