Castle Biosciences’ DecisionDx-Melanoma test, now designated a Breakthrough Device by the FDA, has been ordered over 200,000 times and supported by more than 50 peer-reviewed studies for its role in guiding melanoma care.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Castle Biosciences’ DecisionDx-Melanoma test, a gene expression profile assay developed to inform risk-aligned management for patients with stage I through stage III cutaneous melanoma. The test is designed to assess a patient's individualized risk of sentinel lymph node positivity and recurrence or metastasis, integrating tumor biology with clinical and pathological features via a validated proprietary algorithm.
According to Castle Biosciences, DecisionDx-Melanoma has demonstrated clinical utility in stratifying metastatic risk and predicting nodal involvement. The company reports that the test has been studied in over 10,000 patient samples and supported by more than 50 peer-reviewed publications. Use of the test has been associated with improved patient survival and has exceeded 200,000 orders as of March 31, 2025. It is currently marketed as a laboratory-developed test.
The FDA’s Breakthrough Devices Program is intended to expedite the development and review of devices that may offer more effective diagnosis or treatment of serious or life-threatening conditions compared with existing alternatives. Castle Biosciences indicated plans to pursue formal device marketing authorization and intends to collaborate with the FDA to expand access.
DecisionDx-Melanoma is part of Castle’s broader diagnostic portfolio focused on dermatologic malignancies, including additional offerings skin cancers, uveal melanoma, and Barrett’s esophagus. The company is also developing a test to guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis.
Castle Biosciences noted that the Breakthrough Device designation reflects the potential clinical value of DecisionDx-Melanoma but does not constitute FDA approval. Forward-looking statements regarding performance and outcomes are subject to further validation and regulatory review.
Source: Castle Biosciences Inc