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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.
The FDA grants Breakthrough Device designation to select qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases when compared to currently available alternatives. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment and review.
Posted In: CSTL
