Castle Biosciences Inc. has announced that its DecisionDx®-Melanoma test has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This gene expression profile test is designed to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma by providing personalized insights into a patient's risk of metastasis. The FDA's Breakthrough Device designation is intended to speed up the development and review of devices that offer potential improvements in the treatment or diagnosis of life-threatening conditions. Castle Biosciences plans to submit a device marketing submission to the FDA, aiming to enhance patient care through its innovative test. The grant of this designation is specific to Castle Biosciences, Inc.
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