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

FRIENDSWOOD, Texas, July 23, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its DecisionDx-Melanoma test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). DecisionDx-Melanoma is a gene expression profile (GEP) test that provides comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma.

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