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Castle Biosciences Receives NYS DOH Approval for Skin Cancer Diagnostic

NEW YORK – Dermatologic diagnostics company Castle Biosciences said on Wednesday that it has received approval from the New York State Department of Health for its DecisionDx-SCC test.

Being a permitted laboratory in New York state allows patients there to access the company’s molecular diagnostic tests. Castle has previously received approvals in New York for its other genomic tests, DecisionDx-Melanoma, DecisionDx-UM, and DecisionDx-PRAME, as well as its next-generation sequencing panels, DecisionDx-CMSeq and DecisionDx-UMSeq.

The 40-gene expression profile DecisionDx-SCC test uses an individual patient's tumor biology to predict risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result stratifies patients into a Class 1, 2A, or 2B risk category, helping to inform risk-appropriate management, the company said.

Castle also noted that peer-reviewed publications have shown DecisionDx-SCC to be an independent predictor of metastatic risk, and that integrating the assay with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

"As we continue to grow our suite of genomic tests addressing dermatologic conditions with high clinical need, each milestone is important in the advancement of patient care, including our recent accreditation for the DecisionDx-SCC test in the state of New York," Derek Maetzold, Castle's president and CEO, said in a statement.