The approval marks a significant regulatory milestone for the Friendswood-based company, as New York remains the only U.S. jurisdiction to conduct a formal, rigorous review of laboratory-developed tests before they reach the market. For patients aged 12 and older, the test offers a way to bypass the often lengthy process of trial-and-error with medications.
New York Approves Castle Biosciences’ AdvanceAD-Tx Test
Patients in New York suffering from moderate-to-severe atopic dermatitis now have access to a specialized gene expression test designed to tailor treatment. The state’s Department of Health has cleared Castle Biosciences’ AdvanceAD-Tx, a non-invasive tool that identifies which systemic therapies are most likely to work based on individual biology.
AdvanceAD-Tx analyzes a simple skin scraping to map a patient’s molecular profile, categorizing them as either a JAK inhibitor responder or a candidate for Th2-targeted therapy. According to Kristen Oelschlager, chief operating officer at Castle Biosciences, this validation underscores the company’s commitment to regulatory standards. With this clearance, the firm now has its full portfolio of dermatology, ophthalmology, and gastroenterology tests approved for use in the state.
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