Shares of Castle Biosciences Inc (NASDAQ:CSTL) rose 7.8% after the company announced that its DecisionDx-Melanoma test has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
The diagnostic test, which analyzes gene expression, is designed to offer personalized insights for patients with stage I-III cutaneous melanoma. It aids clinicians in tailoring post-diagnosis treatment plans by estimating a patient’s individual 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 CEO of Castle Biosciences.
The FDA’s Breakthrough Device designation is intended for technologies that have the potential to provide more effective treatment or diagnosis for serious or life-threatening conditions. The designation is meant to streamline development and regulatory review, accelerating access for patients and providers.
Castle Biosciences stated it will pursue a device marketing submission as part of its broader goal to make the test more widely available. The company specializes in creating molecular diagnostics that support clinical decision-making across multiple disease areas.
Castle Biosciences stock price
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