Castle Biosciences Announces New York State Department of Health Approval of its AdvanceAD-Tx™ Test

About this update from Castle Biosciences, Inc.

Approval expands access to Castle's precision medicine test designed to guide systemic treatment decision making in patients with moderate-to-severe atopic dermatitis FRIENDSWOOD, Texas, July 14, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its AdvanceAD-Tx test. AdvanceAD-Tx is a non-invasive gene expression profile test designed to guide systemic therapy selection for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). "We are proud to announce the final approval of our AdvanceAD-Tx test by the NYSDOH's Clinical Laboratory Evaluation Program. This approval makes it easier than ever for patients in New York with moderate-to-severe AD to access a test which helps identify the class of systemic therapy to which they are most likely to respond based on the underlying biology of their disease," said Kristen Oelschlager, chief operating officer at Castle Biosciences. "New York State is the only U.S. jurisdiction that conducts a formal review of laboratory-developed tests before they can be offered to patients; this approval further demonstrates the level of quality and regulatory rigor we seek to achieve with each of our test offerings." With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher® test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh. "Too often, patients with AD spend months on therapies that do not adequately control their disease," said Matthew Goldberg, M.D., senior vice president, medical, at Castle Biosciences. "AdvanceAD-Tx was developed to provide clinicians with objective molecular insight that can help guide a more confident and personalized treatment decision from the start, with the goal of helping patients achieve meaningful relief from their symptoms sooner." AD is a chronic inflammatory skin disease that affects approximately 16.5 million adults and 9.6 million children in the United States. Despite a rapidly expanding treatment landscape, including T helper type 2 (Th2)-targeted biologics and Janus kinase (JAK) inhibitor therapies, identifying the most appropriate systemic therapy for an individual patient remains a major clinical challenge. Patients frequently experience treatment switching and modification due to inadequate response, highlighting the need for molecular tools to guide therapy selection.

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