The DermaSensor device is a handheld, non-invasive device that uses light, through a technology called elastic scattering spectroscopy (ESS) and a validated algorithm to evaluate skin lesions in a matter of seconds. The internal processor analyzes the light reflected from a lesion to objectively help physicians evaluate whether a skin lesion is cancerous through its dichotomous output.
How the Technology Works
The tip of the DermaSensor reflects and records quick bursts of light off the lesion’s cellular structures
The light is analyzed by the built-in computer to distinguish different types of malignant skin lesions (including melanomas, squamous cell carcinomas, and basal cell carcinomas) from benign skin lesions through differences in the ESS spectral signals that are generated for each lesion that is scanned.
By examining the difference in the ESS spectral signals, DermaSensor determines if the skin lesion is at higher risk for malignancy with an “Investigate Further output” or lower risk of malignancy with a “Monitor” output. For lesions with an “Investigate Further” result, the Handheld Unit will display a score from 1 through 10 to indicate the degree of similarity the lesion's spectral recordings are to malignant lesions in studies (i.e., the "spectral similarity” of 1 indicating the least similar to malignant lesions and 10 indicating the most similar to malignant lesions). A pivotal clinical trial showed that higher scores had greater positive predictive value for malignancy. However, lower scores are still classified as "Investigate further" and should be considered as positive output when the device is used in making referral decisions together with clinically relevant information.