DermaSensor Postmarket Surveillance Study

Inclusion criteria

• Men or women of any ethnic group aged 40 and older
• Primary skin lesion suspicious for melanoma
• Patient is willing and able to read, understand, and sign the informed consent form (ICF)

Exclusion criteria

• Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
• Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
• Lesion is greater than 15mm in diameter at the widest point.
• Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.
• Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
• Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).
• Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
• Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).
• Lesion is located on acral skin (e.g., sole or palms).
• Lesion is located within 10mm of the eye.
• Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
• Lesion is located on mucosal surfaces (e.g. genitals, lips).
• Lesion is located in an area with acute sunburn.
• Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits