Customer Service: 866-788-9007

Customer Service: 866-788-9007

Customer Service: 866-788-9007

Diagnostic Tests for Cutaneous Melanoma
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MyPath® Melanoma and
DiffDx-Melanoma Overview

Increased Clarity for Difficult-to-Diagnose Melanocytic Lesions.

MyPath Melanoma and DecisionDx DiffDx Melanoma gene expression profile (GEP) tests are designed to provide objective information to aid in the diagnosis and inform management decisions for patients with ambiguous melanocytic lesions.

A Definitive Diagnosis is Important to Patient Management Decisions

It is estimated that there are over 2 million biopsies of suspected melanoma annually in the U.S. Approximately 85% of these biopsies receive a definitive diagnosis of either benign or malignant by a dermatopathologist using traditional microscopic analyses. However, up to 300,000 lesions cannot be confidently diagnosed with traditional histopathology. These difficult-to-diagnose melanocytic lesions require additional, or ancillary, testing before a definitive diagnosis can be reached. It is important to reduce uncertainty and reach a definitive diagnosis as quickly as possible to inform important patient management decisions regarding primary treatment and follow up.

NCCN guidelines support the use of ancillary testing, including GEP, for indeterminate melanocytic neoplasm following histopathology.

GEP Tests Designed to Reduce Diagnostic Uncertainty

MyPath Melanoma was validated in cutaneous melanocytic lesions to accurately differentiate between benign and malignant melanocytic lesions of unknown potential based on the expression of 23 genes. myPath Melanoma has over 35,000 clinically resulted cases and 9 publications including validation to outcomes.

DiffDx-Melanoma offers a neural network, artificial intelligence-designed algorithm with a low rate of intermediate results. The test was validated in cutaneous melanocytic lesions to accurately differentiate between benign and malignant melanocytic lesions of unknown potential based on the expression of 35 genes.  DiffDx-Melanoma has demonstrated high sensitivity and specificity with a low rate of intermediate results across a wide range of melanocytic subtypes and a high rate of technical success. 

Both GEP tests, myPath Melanoma and DiffDx-Melanoma, are designed to provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better patient care.

Each year approximately 300,000 biopsies for melanocytic lesions are considered difficult-to-diagnose using traditional methods.

myPath Melanoma and DiffDx-Melanoma order forms

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DiffDx-Melanoma