Castle Biosciences Announces Commercial Launch of DecisionDx DiffDx-Melanoma

Castle Biosciences today announced that DecisionDx® DiffDx™-Melanoma is now commercially available. DecisionDx DiffDx-Melanoma is designed for use in patients with suspicious pigmented lesions.

Derek Maetzold, president and chief executive officer of Castle Said: “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, 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.”

Sarah 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.”

DecisionDx 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); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases in 96.6% of the cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value and 99.2% negative predictive value. An intermediate-risk result was identified in 3.6% of the cases.

Castle has three dermatologic cancer gene expression profile tests commercially available in the U.S.: DecisionDx-Melanoma, DecisionDx-SCC and DiffDx-Melanoma. All three tests were developed in-house by Castle and are validated and supported by multiple peer-reviewed publications.

About DecisionDx DiffDx-Melanoma

DecisionDx® DiffDx™-Melanoma (previously known as ConfirmDx-Melanoma) is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

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