Non-Invasive Screening of the Skin

Implications: The company hopes to apply for European regulatory approval next year, with U.S. market approval and launch to follow. The current price of the device is 15,000 EUR. This device promises to be a remarkable time and money saver for medicine. Approximately 80-95% of lesions excised by dermatologists prove non-cancerous when examined histologically. This is wasted time, money and unnecessary anxiety for patients.

Analysis: A Swedish BioTech company has developed a noninvasive device that distinguishes between melanoma, benign nevi, and basal cell carcinoma. In tests with 100 skin cancer lesions and more than 500 benign nevi, the device could distinguish malignant melanoma from benign nevi with 75% specificity at 100% sensitivity. It could also discriminate between non-melanoma skin cancer and benign nevi with 87% specificity at 100% sensitivity. The probe works by differentiating between the electrical impedance characteristics of skin cells. Values are compared to control measurements taken ipsilaterally to the lesion to generate a diagnosis. The sample size of malignant melanoma is too small but the company plans to do more clinical trial work.