Skin cancer is the most common form of cancer worldwide, affecting one in five Americans by age 70.
Detecting skin cancer early is crucial as many cases are preventable through effective sun protection and early diagnosis.
However, delayed diagnoses can lead to increased healthcare costs and morbidity rates.
In response to this pressing issue, Miami-based startup DermaSensor has launched the first FDA-authorized tool in the United States that offers an objective risk assessment for melanoma and other skin cancers.
Recent publications from two pivotal FDA studies highlight the promising impact of DermaSensor’s device.
Together, these studies demonstrated that the hand-held, AI-powered device achieved a notable skin cancer detection sensitivity of 96%, while also helping primary care physicians reduce missed referrals for skin cancer by half.
The studies were conducted in collaboration with esteemed institutions such as Mayo Clinic, Yale University, the University of North Carolina School of Medicine, and SUNY Downstate Health Sciences University.
The multicenter validation study, led by Mayo Clinic, involved the assessment of 1,005 patients and 1,579 lesions across 22 primary care sites.
Out of these evaluations, dermatopathologic analysis confirmed 224 cases of skin cancer, which included melanomas, basal cell carcinomas, and squamous cell carcinomas.
The study revealed that DermaSensor’s device had a sensitivity rate of 96% for skin cancer detection.
In cases where the device returned negative results, the likelihood that a lesion was actually benign was 97%, according to study findings.
The companion study, focused on clinical utility and involving 108 physicians, demonstrated that the use of the device significantly improved physicians’ capabilities to identify and properly refer patients with skin cancer.
When aided by DermaSensor’s device, primary care physicians were able to correctly refer 91.4% of malignant lesions, a considerable increase compared to the 82.0% referral rate without the device.
This advancement resulted in a 50% reduction in missed cancer referrals.
“Since receiving FDA De Novo clearance of this FDA Breakthrough Device last year, there are already hundreds of diverse doctors using our devices, and we are working to quickly scale device adoption so that our device can benefit many of the millions of patients that are diagnosed with skin cancer each year,” stated DermaSensor co-founder and CEO Cody Simmons.
The road to FDA clearance was an eight-year journey for Simmons, who became CEO in January 2016.
Previously, Simmons led business development for a Silicon Valley medical device startup and worked at Genentech.
Maurice Ferre, a Miami medtech serial entrepreneur and the founder of DermaSensor, envisioned this technology as a public health solution to improve access to dermatologic care for early skin cancer detection.
DermaSensor’s device utilizes artificial intelligence and patented spectroscopy technology and is specifically designed for primary care physicians, being the first to identify melanoma, basal cell carcinoma, and squamous cell carcinoma.
Currently, six health systems and numerous private practices have adopted the device, according to Simmons.
In the first quarter of this year, the device was used for over 4,600 customer scans.
A leading health system in Miami was among the first to implement the technology, which marks a significant step forward in the battle against skin cancer.
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