(RTTNews) - Castle Biosciences, Inc. (CSTL), Wednesday said that its DecisionDx-Melanoma test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
DecisionDx-Melanoma is a gene expression profile (GEP) test used to evaluate the risk of recurrence and metastasis 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.
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