A breakthrough in melanoma detection, the Pigmented Lesion Assay (PLA) identifies malignant changes on a genomic level that cannot be seen clinically or by dermatopathology.
The First Non-Invasive Gene Expression Test To Enhance Melanoma Detection
Revolutionary Non-Invasive Adhesive Patches
- Samples the entire lesion, leaving the lesion intact for additional diagnostic procedures and monitoring.1
- Improves patient care and comfort.
- The non-invasive DermTech PLA is well-suited for use in a telemedicine environment.
- Patient care is not delayed.
- Convenient clinician-supervised remote collection avoids unnecessary exposure to patients and physician office staff.
- The DermTech PLA test results help guide essential office visit decisions.
58% of early-stage melanomas are misinterpreted with the current diagnosis pathway.8
Early melanoma may be missed or by histopathology due to the inherent limitation of examining only 1-2% of lesion tissue. In a recent large scale study of pathologists and dermatopathologists in the US, the false negative diagnosis for melanoma in-situ/stage 1a melanoma was found to be 35%. The PLA significantly reduces the number needed to biopsy.
Highly Validated with Proven Clinical Utility
The DermTech PLA is an objective test intended for use on pigmented lesions suspicious for melanoma that meet 1 or more ABCDE criteria to provide accurate, actionable information.9
The PLA collects RNA to measure gene expression across the entire lesion. Gene expression technology improves the negative predictive value (NPV) for early melanoma detection.
The PLA Samples Gene Expression Across the Entire Lesion
Gene Expression May Precede Visible Morphologic Change.10
The PLA focuses on the optimized expression targets of PRAME and LINC.
*Correlation to melanoma with histopathology: LINC + = 7%; PRAME + = 50%; LINC + and PRAME + = 93%.11
PRAME: Preferentially expressed antigen in melanoma
LINC00518: Long intergenic non-coding RNA
DermTech has identified a gene expression ‘signature’ test that is highly correlated with melanoma. Messenger RNA extracted from non-invasively collected skin cells is analyzed for two clinically verified genomic melanoma indicators – LINC0518 and PRAME.
These two genes belong to separate classes of molecules that are known to have roles in oncogenesis, and both are elevated in melanoma. PRAME is a well-described target involved in melanoma progression and metastasis.
Genomic atypia, including mutational and gene expression changes, may precede morphologic change.13
Assessing Gene Expression Consistent with Melanoma Can Aid in Clinical Biopsy Decision Making
PLA negative lesions are generally monitored.
PLA positive lesions are generally surgically biopsied to establish the diagnosis.
- 2-gene (LINC and PRAME) positive samples have a 93% correlation to melanoma diagnosis by histopathology.
- PRAME only positive samples have a 50% correlation to melanoma diagnosis by histopathology.
- LINC only positive samples have a 7% correlation to melanoma diagnosis by histopathology.
“Having the PLA gave me an additional option to obtain objective information to guide my clinical treatment decision.”
– Brook Brouha, M.D., Ph.D.
“Recently, I had a young female patient with a mildly suspicious lesion on the back of her neck. Given the age of the patient, I am not sure I would have done an invasive biopsy on this lesion. Since I have the non-invasive PLA test in my office, I chose to do that first. The test came back positive for both LINC and PRAME and substantiated the need for a surgical biopsy. The histopathology showed a 1.1mm SS MM. You all may have saved her! The lesion didn’t look that bad, so I may have just photographed it and regularly monitored it. Having the PLA gave me an additional option to obtain objective information to guide my clinical treatment decision.”
Dr. Brook Brouha, M.D., Ph.D.
Board Certified Dermatologist & Dermatopathologist
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Instructions for Use