Gene Expression Profile (GEP) Test
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Prospective, Multi-center Study Published in Future Oncology Demonstrates DecisionDx®-Melanoma’s i31-SLNB Result Outperforms Staging Criteria in Identifying Patients with Cutaneous Melanoma Below the 5% NCCN Threshold for Forgoing SLNB
Globenewswire· 2026-03-13 15:02
Core Insights - The publication confirms that DecisionDx-Melanoma's integrated sentinel lymph node biopsy (i31-SLNB) test effectively identifies patients with a low risk of sentinel lymph node (SLN) positivity, outperforming traditional staging criteria and other predictive tests [1][2][8] Group 1: Study Findings - Among patients predicted to have less than 5% risk of SLN positivity, the actual SLN positivity rate was 2.6%, with a three-year recurrence-free survival (RFS) rate of 97.8% [1][5] - In patients with T1b–T2a tumors predicted to have less than 5% risk, the SLN positivity rate was only 1.4% [1] - Patients with a predicted risk greater than 10% had an SLN positivity rate of 21.4%, indicating an 8.2-fold higher likelihood compared to those with low predicted risk [2][5] Group 2: Clinical Implications - The i31-SLNB test integrates a 31-gene expression profile (GEP) score with clinicopathologic factors to provide a personalized risk assessment, supporting decision-making aligned with NCCN guidelines [2][11] - The study demonstrated a true-negative to false-negative (TN:FN) ratio of 55:1 in T1–T2a patients, significantly exceeding the NCCN guideline benchmark of 19:1, indicating superior performance in identifying low-risk patients [7][8] Group 3: Company Overview - Castle Biosciences, Inc. focuses on developing innovative tests that guide patient care, particularly in dermatologic and gastroenterological diseases [13] - The DecisionDx-Melanoma test has been clinically validated in over 10,000 patient samples and has been associated with improved patient survival [12]