The Pigmented Lesion Assay (PLA) is the first non-invasive gene expression test to identify subtle malignancy changes thereby enhancing early melanoma detection. Using adhesive patches, skin tissue is sampled across an entire lesion. RNA is then extracted from the collected skin cells and RT-PCR is used to assess the expression level of specific genes associated with melanoma. Gene expression analysis of two genes, PRAME and LINC00518, allows DermTech to accurately distinguish between melanoma and non-melanoma.
Gene expression changes are detectable before physical changes to the lesion occur. The PLA reduces the probability of missing melanoma to less than 1% (compared to 16% for early stage melanoma with visual assessment and histopathology). In two validation studies comparing the 2-gene expression profile of PRAME and LINC to histopathology diagnosis (n=398), the PLA demonstrated a sensitivity of 91%, a specificity of 69%, and a negative predictive value of 99%.
“The noninvasive pigmented lesion assay enables dermatologists to biopsy fewer benign pigmented skin lesions while missing fewer melanomas.
This result may increase the number of early melanomas biopsied and reduce the number of benign lesions biopsied, thereby improving patient outcomes and reducing healthcare cost.”
— JAMA 2017
Instructions for Use
DermTech’s PLA can aid in the physician’s biopsy decision. The test is intended for use on pigmented lesions suspicious for melanoma that the physician would like additional information prior to surgical biopsy.
PLA USES INCLUDE:
- Lesions that meet one or more ABCDE criteria
- Lesions being followed for change
- Lesions in sensitive areas
- Lesions on patients with potential risks to surgical biopsy including patients who are anti-coagulated, at risk for infection, and at risk for poor wound healing or elevated abnormal scarring
- Lesions on patients that are needle averse or biopsy fatigued