FDA Grants Breakthrough Device Designation to Castle Biosciences' DecisionDx®-Melanoma Test

Core Insights - Castle Biosciences, Inc. announced that its DecisionDx-Melanoma test received Breakthrough Device designation from the FDA, aimed at improving patient care for those diagnosed with stage I-III cutaneous melanoma [1][3] Company Overview - Castle Biosciences 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 [5] - The company has a portfolio that includes tests for skin cancers, Barrett's esophagus, and uveal melanoma, and is engaged in R&D for additional tests in high clinical need areas [6] Product Details - DecisionDx-Melanoma is a gene expression profile test that assesses a patient's risk of sentinel lymph node positivity and melanoma recurrence/metastasis, integrating tumor biology with clinical factors [4] - The test has been validated through over 10,000 patient samples and is supported by more than 50 peer-reviewed studies, demonstrating its clinical value and association with improved patient survival [4] - As of March 31, 2025, DecisionDx-Melanoma has been ordered over 200,000 times for patients diagnosed with cutaneous melanoma [4]