DermaSensor’s Device with FDA Breakthrough Designation Demonstrated 96.2% Sensitivity for Detecting Melanoma in Patients Aged 65 and Older
MIAMI, July 13, 2023, Business Wire — DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented to the 11th Annual American Dermoscopy Meeting a sub-analysis of the DERM-ASSESS III study data focusing on Medicare-eligible patients.1 DermaSensor was able to correctly identify 96.2% of melanomas in patients 65 and older, highlighting the device’s potential to help increase access to potentially lifesaving skin cancer detection for millions of at-risk Medicare patients.2
In 2023, it is estimated that 186,680 cases of melanoma will be diagnosed in the U.S., with the mortality and morbidity of disease highly associated with the stage at which the cancer is detected. The estimated 5-year survival rate for patients whose melanoma is detected early is over 99%, while the survival rate falls to 71% when the disease reaches the lymph nodes and 32% when the disease metastasizes to distant organs.3 In the DERM-ASSESS III study, the sensitivity of the DermaSensor device for melanoma detection was comparable to that of the participating dermatologists.2
“With melanoma, timing is everything. In the hands of PCPs, I expect the DermaSensor device to help improve the detection of melanoma. This would result in improved, accelerated referrals to dermatologists, and that could save many Medicare patients’ lives.”— Dr. Harold Rabinovitz, a board certified dermatologist and fellowship trained Mohs surgeon
The DermaSensor device is designed as an objective, non-invasive tool that can be used by PCPs during an exam to support the rapid, point-of-care assessment of lesions suggestive of skin cancer. The device was granted FDA Breakthrough Device designation and is currently under review by the FDA.
“With compelling clinical evidence in a Medicare population and FDA-breakthrough indication, DermaSensor plans to work directly with the Centers for Medicare & Medicaid Services (CMS) to explore how we can make our skin cancer detection technology accessible to Medicare patients,” said DermaSensor’s CEO, Cody Simmons. “We’re working diligently towards a reality where Medicare patients at the highest risk of skin cancer can receive an AI-assisted skin cancer exam in just a few minutes from the convenience of their local primary care office.”
There were no device-related safety issues reported in the study. The studies included investigators and authors from Brigham and Women’s Hospital, UC Davis School of Medicine, Yale University School of Medicine, University of Connecticut Dermatology Department, and the University of Florida Dermatology Department.
- DermaSensor. (2022, March 22). DermaSensor, Inc Announces Positive Results From Melanoma Clinical Validation Study of Skin Cancer Detection Device [Press Release]
- Hartman RI, et al. Melanoma Detection in the Medicare Population: Sub-analysis of DERM-ASSESS III, a Validation Study of a Handheld Elastic Scattering Spectroscopy Device on Lesions Suggestive of Melanoma. Poster Presentation, ADM, Stowe, VT, July 13-15, 2023.
- Cancer Facts and Figures 2023. American Cancer Society