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Castle Bio Gets NY State Approval for Three Cancer Tests

NEW YORK (GenomeWeb) – Castle Bioscience said today that it has received a clinical laboratory permit from the New York State Department of Health, allowing the company to offer three of its PCR-based expression profile cancer tests in the state.

According to Castle Bio, it now has NYSDOH approval for DecisionDx-Melanoma, which is designed to identify high-risk Stage I and II melanoma patients; DecisionDx-UM for assessing metastatic risk for newly diagnosed uveal melanoma patients; and DecisionDx-PRAME for measuring gene expression levels associated with increased metastatic risk in Class 1 uveal melanoma patients. All of the tests are offered out of the company's CLIA-certified, CAP-accredited laboratory in Phoenix.

"Successfully completing the rigorous New York State licensure process, which involves laboratory inspection, as well as individual test approval, reflects our facility's high quality standards," Kristen Oelschlager, vice president of clinical operations at Castle Bio, said in a statement.