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Castle Biosciences Announces Commercial Launch of DecisionDx DiffDx-Melanoma
Diagnostic gene expression profile test for suspicious pigmented lesions now commercially available in the U.S. FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle
About this update from Castle Biosciences, Inc.
[{"type":"text","content":"\nDiagnostic gene expression profile test for suspicious pigmented lesions now commercially available in the U.S.\n\n FRIENDSWOOD, Texas--(BUSINESS WIRE)--\nCastle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that DecisionDx® DiffDx™-Melanoma is now commercially available. DecisionDx DiffDx-Melanoma is designed for use in patients with suspicious pigmented lesions.\n\n“We are pleased to offer DecisionDx DiffDx-Melanoma, which has been designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions as benign or malignant,” said Derek Maetzold, president and chief executive officer of Castle. “I am particularly proud of our research and development team, who successfully maintained timelines from program initiation to validation. And employing our artificial intelligence tools, we were able to achieve our target product profile goals for DiffDx-Melanoma: improved accuracy metrics with a substantially reduced intermediate-risk zone, to enable dermatopathologists to act upon a test result from DiffDx-Melanoma. This test has been demonstrated to provide a definitive result in more than 96% of the reported cases, which allows for clinicians to have a greater, direct impact on patient care.”\n\nSarah I. Estrada, M.D., FCAP, laboratory director of Affiliated Dermatology® added, “Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. Undertreatment or delayed identification of melanoma can lead to tumor spread and increased risk of melanoma-specific mortality. On the other hand, overtreatment can impact patient quality of life, potentially resulting in adverse events and increased morbidity. DecisionDx DiffDx-Melanoma is designed to provide diagnostic clarity for dermatopathologists and help dermatologists deliver more informed patient management plans.”\n\nDecisionDx DiffDx-Melanoma is a gene expression profile (GEP) test designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions and classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); inte...