MIAMI--(BUSINESS WIRE)--DermaSensor Inc., a health technology company designing non-invasive tools to better equip primary care physicians for skin cancer detection, today announced the publication of research demonstrating that its device can help clinicians more accurately detect skin cancer, while also effectively ruling out the majority of referrals of benign lesions that patients were concerned were cancerous.
The study assessed the accuracy and value of the DermaSensor device in helping primary care clinicians (PCC) differentiate between benign and malignant lesions and was published in the Journal of the American Board of Family Medicine (JABFM).
“Detecting skin cancer early is crucial, as it can be treated successfully when found early,” said Nathalie Zeitouni, MD, a nationally recognized Mohs and reconstructive surgeon at Medical Dermatology Specialists in Phoenix and one of the study’s 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 panel1:
- The DermaSensor device had a sensitivity of 90.0% and specificity of 60.7%, meaningfully outperforming the clinicians' standard of care management sensitivity of 40.0% 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 Negative Predictive Value (NPV) of 98.9%, 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,” said Gary Slatko, MD, Chief Medical Officer of DermaSensor. “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 1 in 5 Americans developing it by the age of 70.2 Wait times for dermatologist appointments can exceed 5 months.3 To help address this urgent 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 FDA submission and labeling. DermaSensor received FDA clearance in January 2024.
About DermaSensor
DermaSensor Inc. is a health technology company designing non-invasive tools to better equip all physicians for skin cancer detection. The DermaSensor device is an affordable, handheld tool that uses spectroscopy and algorithms to test skin lesions for cancer in seconds. It is currently FDA Cleared, CE Marked, and is available for sale in the U.S.
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.
