Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

Inclusion Criteria

• Males and females at least 21 years of age
• Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
• The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
• Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
• Willing to have DermTech adhesive patch biopsies performed
• Must be able to complete study procedures as required by the protocol
• Willing to provide informed consent to participate in this trial

Exclusion Criteria

• Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
• Has an ulcerated or bleeding lesion that could confound the biopsy results
• Has a suspicious lesion(s) in an area that was previously surgically biopsied
• Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
• The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
• Has a known sensitivity to adhesive patches
• Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study
• Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)
• Suspected non-melanoma skin cancer
• Patients with contraindication(s) to surgical biopsy -