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.
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.
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
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.
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