On January 16, the US Food and Drug Administration granted clearance to a skin cancer detection device powered by artificial intelligence.
Innovation in Skin Cancer Detection
The handheld device, called DermaSensor, works by assessing the characteristics of lesions at both the cellular level and beneath the surface of the skin. It uses AI-powered spectroscopy to provide quantitative, point-of-testing identification of skin cancer.
The device provides real-time, objective results with the use of an algorithm based on data collected from over 4,000 malignant and benign lesions. It helps spot melanoma, the most deadly form of skin cancer. It can also assess moles for basal cell carcinoma and squamous cell carcinoma. The data it provides will signal the physicians whether a suspicious lesion should be investigated further.
We are currently entering the golden age of predictive and generative AI in healthcare. According to DermaSensor Inc. co-founder and CEO Cody Simmons, these capabilities are now being paired with new types of technology, such as genetic sequencing and spectroscopy to optimize disease detection and care. The Miami-based device maker began its patient enrollment in its FDA pivotal study in mid-2020, and now it has received clearance of designated De Novo submission.
Simmons believes that equipping the primary care physicians (PCPs) to evaluate the most common cancer in the US has been a major, long-standing unmet need in medicine. Physicians are usually reliant on subjective physician judgment using the naked eye or through a microscope.
According to the American Academy of Dermatology, one in five Americans will have developed a form of skin cancer by the age of 70. This puts the cost of treatment in the US at over $8 billion. Meanwhile, most skin cancers are actually curable if they are detected early.
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Green Light From FDA
FDA clarifies that the device should be used in conjunction with clinically relevant information obtained from the clinical assessment. This includes visual analysis of the lesion by physicians who are not dermatologists. The agency also added that DermaSensor is for use only in patients ages 40 and up.
The FDA also requires additional validation testing in patients from various representative demographic groups, including those at risk of skin cancer. While it is not designed to be used as a primary screening tool, this novel technology can further skin lesions which have already been flagged as suspicious by doctors.
The approval follows an observational study (NCT05126173)led by the Mayo Clinic which evaluated the device in over 1,000 patients from across 22 study centers. The DERM-SUCCESS study revealed that the device showed sensitivity of 96% across all 224 forms of skin cancer and across different skin types. Negative results from DermaSensor also had a 97% chance of being benign across all types of skin cancer.
Another clinical utility study also investigated the usage of DermaSensor with 108 physicians. The study revealed that the device decreased the number of missed skin cancers by half. Furthermore ,the study observed that the use of DermaSensor led physicians to refer more patients for skin cancer.
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