GEP test for melanoma proves accurate in validation study

Recently released results of a clinical validation study suggest that a new gene expression profile (GEP) test is effective for cutaneous melanoma.

The study concludes that DecisionDx-Melanoma, a GEP test from Castle Biosciences Inc., Friendswood, Texas, accurately predicts metastatic risk in Stage I or Stage II melanoma patients who have no sign of disease beyond the original tumor. The study finds that the test can predict independent of current diagnostic modalities, including American Joint Committee on Cancer (AJCC) staging.

In the multicenter study, formalin-fixed, paraffin-embedded specimens from biopsy or wide excision procedures of primary cutaneous melanoma tumors were analyzed to observe changes in the expression of 28 discriminating genes plus three 3 control genes. Based on the GEP test results, melanoma tumors were classified as either Class 1 or Class 2. Patients’ clinical outcomes at five years post-diagnosis were compared with the GEP test prediction.

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Gene Test Validation