Why GEP?

Guidelines Support GEP Testing in Ambiguous Melanocytic Lesions

MyPath Melanoma is a clinically validated, accurate and objective gene expression profile (GEP) test intended to resolve diagnostic ambiguity for melanocytic lesions of uncertain malignant potential.

National Comprehensive Cancer Network (NCCN)

Guidelines for Cutaneous Melanoma Principles of Molecular Testing

The NCCN guidelines describe the utility of diagnostic ancillary testing including GEP to aid in differentiating benign from malignant lesions. These tests facilitate a more definitive diagnosis and guide treatment decisions in lesions that are diagnostically ambiguous

American Society of Dermatopathology (ASDP)

Appropriate use criteria for ancillary diagnostic testing in dermatopathology

The ASDP’s appropriate use criteria committee has designated six key clinical scenarios in dermatopathology as "majority usually appropriate" for ancillary diagnostic GEP testing. These scenarios include melanocytic lesions in adult and pediatric patients for which a distinction between benign melanocytic nevus and melanoma cannot be made

American Academy of Dermatology (AAD)

Guidelines of care for the management of primary cutaneous melanoma

The AAD supports the use of ancillary diagnostic molecular techniques (e.g., GEP, CGH, FISH) for equivocal melanocytic neoplasms. These tests may help to differentiate benign nevi from cutaneous melanoma, including atypical Spitz tumors.

NCCN Guidelines Version 3. 2022. Melanoma: Cutaneous.
Fung et al., J Cutan Pathol. e-pub 18 Sept 2021;1-15.
Swetter et al., 2019;80(1):208-250.

GEP Testing Is Designed to Help Differentiate Benign Melanocytic Nevi From Malignant Melanomas

When a distinction cannot be made through clinical and histopathologic approaches like FISH, CGH, and SNP array, GEP testing is used to guide the accurate interpretation of melanocytic neoplasms whose histopathologic features are ambiguous or conflicting.

But unlike those methods, which rely on the detection of abnormalities in DNA structure, GEP testing measures RNA to detect a specific pattern of gene expression that occurs in most malignant melanomas but not in benign nevi.

GEP Testing Can Help Reduce This Diagnostic Uncertainty

DNA

FISH, CGH, SNP, NGS

Captures DNA abnormalities
Point mutations like BRAF
DNA Abnormalities in RREB1, MYC, p16.

Transcription

RNA

Gene Expression (GEP) captures abnormalities in the function of the genes

myPath® Melanoma
DiffDx™-Melanoma

Translation

Protein

Immunohistochemistry captures cell membrane protein expression

S100A PRAME

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Why GEP?

Guidelines Support GEP Testing in Ambiguous Melanocytic Lesions

GEP Testing Is Designed to Help Differentiate Benign Melanocytic Nevi From Malignant Melanomas

GEP Testing Can Help Reduce This Diagnostic Uncertainty

DNA

DNA

RNA

RNA

Protein