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Investing.com -- Castle Biosciences Inc (NASDAQ:CSTL) stock surged 7.8% after the company announced that its DecisionDx-Melanoma test received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
The gene expression profile test provides personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma. The test helps inform clinicians’ post-diagnosis decision making based on a patient’s individual predicted risk of metastasis.
"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," said Derek Maetzold, president and chief executive officer of Castle Biosciences.
The FDA’s Breakthrough Device designation is granted to qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases compared to currently available alternatives. The program aims to provide patients and healthcare providers with faster access to medical devices by expediting development, assessment and review processes.
Castle Biosciences plans to submit a device marketing submission to the FDA as it works to expand access to the test. The company focuses on developing innovative tests that guide patient care across various medical conditions.
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