DermTech’s Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years

Inclusion Criteria:

Males and females the treating physician chose to use the PLA on;
Presence of a lesion(s) that is suspicious for melanoma and a candidate for surgical biopsy that was previously biopsied with DermTech's adhesive patch biopsy and assessed via PLA;
Willing to permit subsequent PLA assays to be performed on suspicious lesions;
Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
Subjects must be able to complete study visits required by the protocol (subject is not planning to relocate or travel thus prevent attendance at future study visits; and
Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
Has an ulcerated or bleeding lesion that could cofound the PLA results;
Has a suspicious lesion(s) in an area that was previously surgically biopsied;
The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
Has an allergy to tape or latex rubber;
Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study; and
Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule of events. -