Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

Inclusion Criteria: * Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy. * The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS. * Male and female ≥ 21 years old. * Subject is capable of giving written informed consent. * Primary excision. Exclusion Criteria: * The lesion is less than 1 cm from the eyes. * The lesion is on the palms of hands or soles of the feet. * Mucosal lesion. * Pregnant females. * Low study procedure compliance. * Patients who are mentally or physically unable to comply with all aspects of the study. * Undergoing chemotherapy. * Minor or legally incompetent and not able to sign the consent form. * Patient previously tested by MDS and was diagnosed with melanoma during the study.