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New Data Confirms Performance of DecisionDx®-Melanoma to Identify Patients with Less Than Five Percent Risk of Sentinel Lymph Node Positivity
Globenewswire· 2025-11-14 12:00
Core Insights - Castle Biosciences, Inc. announced new data showcasing the clinical value of its DecisionDx-Melanoma test in enhancing sentinel lymph node biopsy decision-making and recurrence risk prediction for patients with cutaneous melanoma [1][2] Group 1: Clinical Value of DecisionDx-Melanoma - The DecisionDx-Melanoma test helps physicians make informed decisions regarding sentinel lymph node biopsy by accurately identifying patients with low likelihood of sentinel node positivity, allowing some to safely forgo the procedure [2][4] - Current guidelines suggest considering SLNB when the estimated probability of a positive node exceeds 5%, but up to 88% of SLNB procedures yield negative results, highlighting the need for better identification tools [2][4] - The test utilizes tumor biology to generate a personalized risk assessment, combining gene-expression profiling with clinicopathologic features to support patient management decisions [2][6] Group 2: Study Findings and Presentations - At the 2nd European Congress on Dermato-Oncology, two studies will be presented, demonstrating that the i31-SLNB algorithm outperforms the MIA nomogram in predicting SLN positivity [3][4] - The i31-SLNB algorithm showed an AUC of 0.74 compared to 0.61 for the MIA nomogram, indicating superior sensitivity and specificity in identifying patients at low (<5%) and high (>10%) risk of SLN positivity [4][11] - In a multicenter study of 810 patients, the DecisionDx-Melanoma test was found to be an independent predictor of recurrence, significantly improving risk prediction beyond AJCC staging alone [11]