FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced results from a study evaluating the prognostic accuracy of the DecisionDx®-Melanoma gene expression profile (GEP) test in a cohort of patients with head and neck melanoma. Results demonstrated that the DecisionDx-Melanoma test accurately identifies metastatic risk for these clinically challenging patients, and can add valuable information beyond the use of traditional staging techniques such as sentinel lymph node biopsy (SLNB). The data were presented during the American College of Mohs Surgery 49th Annual Meeting (ACMS), held in San Francisco, CA from April 27-30.
In the study, “Prognostic Accuracy of a 31-Gene Expression Profile (GEP) in a Cohort of Patients with Cutaneous Melanoma of the Head and Neck” (Abstract #10), primary tumor tissue from 178 patients with cutaneous melanoma (CM) of the head and neck region—of whom 121 had documented SLNB results—was analyzed using the DecisionDx-Melanoma test under an IRB-approved multicenter protocol. Based on results from the GEP test, patients were assigned to either Class 1 (low risk) or Class 2 (high risk). To further refine risk prediction, patients were assigned a sub-classification of either “A” or “B” to reflect a better or worse prognosis, respectively, based on the proximity of their result to the crossover point between classes. Primary endpoints were recurrence-free survival (RFS) as defined by time to either regional or distant metastasis, distant metastasis-free survival (DMFS) as defined by time to any metastatic event beyond the primary tumor, and melanoma-specific survival (MSS) as defined by time from diagnosis to death resulting from melanoma. Survival rates by sentinel lymph node (SLN) status were also included for patients who underwent SLN biopsy.
