Castle Biosciences, Inc. Announces New York Approval of Decisiondx Diffdx-Melanoma
September 16, 2021 at 07:00 am EDT
Share
Castle Biosciences, Inc. announced that it has received approval from the New York State Department of Health for its proprietary DecisionDx DiffDx-Melanoma gene expression profile (GEP) test. DecisionDx DiffDx-Melanoma is designed to provide an objective and comprehensive diagnostic offering to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. In May of 2021, Castle acquired myPath Melanoma, a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Together, myPath Melanoma and DecisionDx DiffDx-Melanoma comprise Castle’s comprehensive diagnostic offering for difficult-to-diagnose melanocytic lesions. Both GEP tests, myPath Melanoma and DiffDx-Melanoma, are designed to provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better patient care. Castle previously received approvals in the state of New York for its other GEP tests, including DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx-UM and DecisionDx-PRAME, as well as its next generation sequencing panels, DecisionDx-CMSeq and DecisionDx-UMSeq.
Castle Biosciences, Inc. is a commercial-stage diagnostics company. The Company is focused on providing physicians and their patients with personalized, clinically actionable information to clinicians and their patients to inform treatment decisions and improve health outcomes. Its portfolio consists of tests for skin cancers, uveal melanoma, Barretts esophagus and mental health conditions. Its products include DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma, TissueCypher, and DecisionDx-UM, IDgenetix. DecisionDx-Melanoma is a risk stratification gene expression profile (GEP) test that predicts the risk of metastasis, or recurrence, for patients diagnosed with invasive cutaneous melanoma (CM), a deadly skin cancer. MyPath Melanoma is GEP test offering for patients with difficult-to-diagnose melanocytic lesions. IDgenetix is pharmacogenomics (PGx) test that helps to guide optimal drug treatment for patients diagnosed with major depressive disorder, bipolar disorder, and other.