Genetic Risk Stratification of Pediatric Skin Lesions

Genetic Risk Stratification of Pediatric Skin Lesions

A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.

Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.

Inclusion Criteria:

• 20 years of age or younger.
• Subjects or parents willing and able to give informed consent, and assent as appropriate
• Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months

Exclusion Criteria:

• Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed
• Bleeding or ulcerated lesions
• Previously biopsied, scarred, or known melanoma lesions
• Presence of active psoriasis/eczema/other skin condition in area to be biopsied