The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Castle’s DecisionDx-Melanoma.
The FDA grants Breakthrough Device designation to select qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases when compared to currently available alternatives. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up the development, assessment, and review process.
“We believe this recognition by the FDA supports DecisionDx-Melanoma’s potential to significantly improve melanoma outcomes by delivering personalized care to those who need it most,” says Derek Maetzold, President and Chief Executive Officer of Castle Biosciences, in a news release. “We expect to submit a device marketing submission to the FDA and look forward to working with the agency to help more patients access these potentially life-changing insights.”
DecisionDx-Melanoma is a gene expression profile risk stratification test that is designed to provide information on a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis.
