FDA Grants Breakthrough Device Status to Castle Biosciences' DecisionDx-Melanoma Test

Castle Biosciences announced that its DecisionDx-Melanoma test has been granted Breakthrough Device designation by the FDA. The test provides personalized results to guide risk-aligned management decisions for stage I-III cutaneous melanoma patients. The FDA grants Breakthrough Device designation to select devices offering improved treatment or diagnosis of life-threatening diseases.

Castle Biosciences, Inc. (Nasdaq: CSTL), a leading diagnostics company, announced that its DecisionDx-Melanoma test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This designation recognizes the test's potential to significantly improve melanoma outcomes by providing personalized care to patients with stage I-III cutaneous melanoma.

DecisionDx-Melanoma is a gene expression profile (GEP) test that offers comprehensive, personalized results to guide risk-aligned management decisions for melanoma patients. The test provides valuable biological insights that help inform clinicians' post-diagnosis decision-making based on a patient's individual predicted risk of metastasis [1].

The FDA grants Breakthrough Device designation to select devices that offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This designation accelerates the development, assessment, and review process, providing patients and healthcare providers with timely access to potentially life-changing medical devices [2].

Castle Biosciences plans to submit a device marketing submission to the FDA, aiming to expand access to this diagnostic tool. The company believes that DecisionDx-Melanoma's clinical performance 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 [1].

The Breakthrough Device designation for DecisionDx-Melanoma creates an accelerated regulatory pathway, which could significantly enhance market access and clinical integration. This designation is expected to transition the test from its current status as a Laboratory Developed Test (LDT) to an FDA-cleared/approved diagnostic, potentially improving adoption, reimbursement potential, and market positioning [2].

Castle Biosciences' DecisionDx-Melanoma test has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. Its clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results [1].

References:
[1] https://www.globenewswire.com/news-release/2025/07/23/3120087/0/en/FDA-Grants-Breakthrough-Device-Designation-to-Castle-Biosciences-DecisionDx-Melanoma-Test.html
[2] https://www.stocktitan.net/news/CSTL/fda-grants-breakthrough-device-designation-to-castle-biosciences-qyg50vu8da8f.html