Castle Biosciences(US:CSTL) Globenewswire·2025-12-17 12:00Core Insights - Castle Biosciences, Inc. announced new data from the largest prospective, multicenter study comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and PRAME gene expression for predicting outcomes in uveal melanoma (UM) patients [1][2] Study Findings - The study validated that the combination of DecisionDx-UM and PRAME provides more precise metastatic risk prediction for UM patients than either test used independently [2] - The combination of DecisionDx-UM and PRAME delivers superior predictions of metastasis-free survival (MFS) and overall survival (OS) compared to NGS-based mutation analysis [2] - The study analyzed 1,140 primary UM tumors, including 131 small, early-stage tumors, using NGS to assess seven clusters of recurrent genetic mutations [2] Test Offerings - Castle currently offers three tests for UM: DecisionDx-UM, DecisionDx-PRAME, and DecisionDx-UMSeq, all from a single biopsy sample [3] - These tests provide comprehensive molecular insights for precise risk assessment and informed treatment planning for UM patients [3] Collaborative Ocular Oncology Group (COOG) - COOG is the largest collaborative working group in North America focused on intraocular cancers, particularly uveal melanoma, comprising over 25 leading academic and private ocular oncology centers [4] - COOG has conducted two large multicenter prospective studies of prognostic biomarkers in uveal melanoma, the first of their kind in this cancer [4] DecisionDx-UM Overview - DecisionDx-UM is a gene expression profile test that predicts personalized risk of metastasis from uveal melanoma by stratifying patients into low-, intermediate-, or high-risk groups [5] - The test has been widely adopted as the standard of care in the U.S. and is included in the AJCC Staging Manual and NCCN Guidelines, with nearly 80% of newly diagnosed patients undergoing testing [6]