DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors.

Castle Biosciences, Inc.’s DecisionDx-Melanoma is a significant, independent predictor of patient outcomes in cutaneous melanoma.

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors.

The study is published in JCO Precision Oncology.

Consistent with previous prospective validation and performance studies, the DecisionDx-Melanoma test was significantly associated with the outcomes of recurrence-free (RFS), distant metastasis-free (DMFS) and overall survival (OS) in univariate analysis of patients diagnosed with stage I-III melanoma, the study showed. 

The test’s result was also a significant, independent predictor of the same endpoints when compared to American Joint Committee on Cancer (AJCC) 8th Edition staging system in multivariable analysis. Additionally, study authors conclude that combining DecisionDx-Melanoma test results with AJCC staging enhances sensitivity and negative predictive value over each approach alone, identifying those who may benefit from more or less intense follow-up. Further, accurate risk stratification by the DecisionDx-Melanoma test was demonstrated in the cohort of patients with stage I-IIA melanoma, a group that is currently recommended to receive low-intensity management but that contributes substantially to the number of patients who die from melanoma each year.

“The most impactful measures of appropriate melanoma management include survival time and the quality of that time post-diagnosis,” says first author Eddy Hsueh, M.D., surgical oncologist at St. Louis University, St. Louis, MO, in a news release. “In this study, we demonstrated that DecisionDx-Melanoma results are significant predictors of real-world recurrence and metastasis rates, which suggests that the test can provide clinically actionable information when making cancer management decisions in early-stage melanoma.”