Timely diagnosis of skin cancer can reduce patient mortality and morbidity, while also cutting down healthcare costs for treatment. DermaSensor has presented the results of clinical trials for its new device that could help detect skin cancer. The company’s non-invasive tool was able to correctly classify 94% of 338 high-risk skin lesions and 23% of 1,681 low-risk lesions that were biopsied by physicians for suspicion of skin cancer. The technology uses spectroscopy and proved to be more sensitive than primary care physicians for all common skin cancers.
Skin cancer is a prevalent form of cancer in the US, with melanoma projected to become the second most common cancer by 2040. Given the abundance of primary care physicians in the country, the DermaSensor device has the potential to facilitate rapid, point-of-care assessment of skin lesions that might suggest skin cancer. The device was granted FDA Breakthrough Device status and is currently undergoing FDA review. The company hopes to soon equip primary care physicians in the US with their handheld, wireless device to improve skin cancer detection and referral.
The cancer device has undergone two clinical studies that included over 2,000 suspicious lesions, biopsied by 32 study centers. The clinical studies revealed that the device correctly classified benign lesions biopsied by physicians with a specificity of 21%. A negative device result was 98% accurate in ruling out melanoma, while a positive device result indicated melanoma in approximately one out of every six cases. There were no device-related safety issues reported in either study.
The studies included investigators and authors from medical institutions such as Mayo Clinic, Harvard School of Medicine, and Yale School of Medicine.
