Real-World Study Confirms Long-Term Performance of DecisionDx®-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with the DecisionDx-UM Class Result

Core Insights - Castle Biosciences announced new data from the independent validation of the Collaborative Ocular Oncology Group Study No. 2 (COOG2.1), highlighting the importance of adding PRAME gene expression information to the DecisionDx-UM test for predicting metastatic risk in uveal melanoma patients [1][2] Group 1: Company Overview - Castle Biosciences, Inc. is a diagnostics company focused on innovative tests that guide patient care, with a mission to transform disease management by prioritizing patients, clinicians, employees, and investors [4] - The company's current portfolio includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, with ongoing research for additional tests in high clinical need areas [5] Group 2: DecisionDx-UM Test - DecisionDx-UM is a 15-gene expression profile test that predicts the risk of metastasis in uveal melanoma patients, recognized as the standard of care in the majority of ocular oncology practices in the U.S. [3] - The test has been validated in prospective, multi-center studies and is considered a superior predictor of metastasis compared to other factors like chromosome 3 status and AJCC stage [3] - Approximately 80% of uveal melanoma patients in the U.S. undergo the DecisionDx-UM test as part of their diagnostic process [3] Group 3: Research Findings - The recent study presented at the ARVO 2025 Annual Meeting involved a cohort of 1,297 uveal melanoma patients, confirming the long-term performance of the DecisionDx-UM test and the clinical value of PRAME as an adjunct biomarker [2][5] - The findings indicate that combining PRAME status with DecisionDx-UM results can further refine risk stratification, providing clinicians with better insights for treatment decisions [5]