Castle Biosciences DecisionDx DiffDx-Melanoma

Castle Biosciences has launched DecisionDx DiffDx-Melanoma, a gene expression profile test for use in patients with suspicious pigmented lesions. The test is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions, and classifies these lesions as either 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 at a rate of 96.6 percent, with 99.1 percent sensitivity, 94.3 percent specificity, 93.6 percent positive predictive value, and 99.2 percent negative predictive value, the company said. An intermediate-risk result was identified in 3.6 percent of the cases.