The New York State Department of Health (NYSDOH) has approved Castle Biosciences, Inc.’s AdvanceAD-Tx test, expanding access to the 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). The test analyzes a patient’s individual disease biology from a non-invasive skin sample to classify them into one of two molecular profiles — a Janus Kinase (JAK) Inhibitor Responder Profile or a Th2 Molecular Profile — providing clinicians with objective molecular insight to help guide systemic treatment selection.
“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,” says Kristen Oelschlager, Chief Operating Officer at Castle Biosciences, in a news release. “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.”
“Too often, patients with AD spend months on therapies that do not adequately control their disease,” adds Matthew Goldberg, MD, 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.”
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.
Derek Maetzold, President and Chief Executive Officer of Castle Biosciences, reviews AdvanceAD-Tx’s power and promise.
