Decision DX melanoma

A gene expression profile test is being widely used to determine metastatic risk in Stage I and II cutaneous melanoma patients.

An accurate, independent predictor of a patient’s metastatic risk.

It is an independent of Breslow’s thickness, ulceration status and mitotic rate; AJCC stage, and Sentinel Lymph Node Biopsy status.

Performed on formalin-fixed, paraffin embedded primary tumor tissue.

With cutaneous melanoma there is wide variability in metastatic rates within and across TNM stage groupings.

Sentinel lymph node status has been reported as the most accurate prognostic factor, however two of three patients who metastasize are SLNB negative.

Gene expression profile assay has been shown to be a more accurate predictor of metastasis than current staging methods

The assay analyzes the expression of 31 genes within melanomas, and more accurately predicts distant metastases in Stages I and II patients than can current staging factors (AJCC stage, Breslow’s thickness, ulceration status, mitotic rate and sentinel lymph node status).

This gene expression test stratifies tumors as low risk (Class 1) or high risk (Class 2).

Class 1 tumors were found to have a 5-year metastasis free survival rate of 97%, while those in Class 2 have a 5-year metastasis free survival of 31% (Gerami et al).

DecisionDx-Melanoma test identifies metastatic risk in sentinel lymph node negative patients.

Patients with Class 2 biology have a significantly higher risk than most Stage III patients.

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