Data published in the Journal of the American Board of Family Medicine shows that DermaSensor’s
elastic scattering spectroscopy device improves primary care clinicians’ ability to assess skin lesions
Miami, September 19, 2024 (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 panel 1:
● 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 702. Wait times for dermatologist appointments can exceed 5 months3.
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.
DermaSensor Press Contact
Jessica Masuga
Senior Account Director
New Dawn Communications
jmasuga@newdawncomms.com
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/.
3Merritt Hawkins. 2017 Survey of Physician Appointment Wait Times.
https://www.aristamd.com/wp-content/uploads/2018/11/mha2017waittimesurveyPDF-1.pdf.
Source: DermaSensor Inc.
