NEW YORK – Dermatologic diagnostics company Castle Biosciences said on Thursday that it has received approval from the New York State Department of Health for its DecisionDx DiffDx-Melanoma gene expression profile test.
DiffDx-Melanoma is meant to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions for which a treatment plan can be uncertain. Data obtained from DiffDx-Melanoma can also be augmented by other clinical, laboratory, and histopathologic information, as well as data from Castle's myPath Melanoma test, which is also designed to help dermatopathologists and dermatologists deliver more informed patient management plans.
Castle acquired myPath Melanoma in May from Myriad Genetics. The assay is 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.
"For patients in New York with ambiguous melanocytic lesions, we believe access to our DecisionDx DiffDx-Melanoma test can provide clarity in the management of their disease for improved overall outcomes," Kristen Oelschlager, Castle's chief operating officer, said in a statement.
Castle has previously received approvals in 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.
In Thursday morning trade on the Nasdaq, shares of Castle Biosciences were down around 1 percent at $73.71.