Castle Biosciences announces DecisionDx-Melanoma test granted BD designation

Castle Biosciences (CSTL) announced that its DecisionDx-Melanoma test has been granted Breakthrough Device, BD, 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. “DecisionDx-Melanoma provides valuable biological insights that help inform clinicians’ post-diagnosis decision making based on a patient’s individual predicted risk of metastasis,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We believe the clinical performance of our DecisionDx-Melanoma test is unmatched by other tests currently on the market, both in its ability to provide precise and clinically meaningful risk stratification as well as accurate predictions of sentinel lymph node positivity.