New York approved Castle's non-invasive gene expression test for patients 12 and older with moderate-to-severe atopic dermatitis, expanding access in a state that formally reviews laboratory-developed tests before they can be offered.
Castle Biosciences said it received assay approval from the New York State Department of Health for AdvanceAD-Tx, 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. The company said New York is the only U.S. jurisdiction that formally reviews laboratory-developed tests before they can be offered to patients, making the decision a notable regulatory step for diagnostics companies seeking access to the state. AdvanceAD-Tx analyzes RNA expression data from lesional skin scraping samples to classify patients into either a JAK Inhibitor Responder Profile or a Th2 Molecular Profile, aiming to help clinicians choose between systemic treatment approaches based on underlying disease biology. Castle said the approval means it now has New York State approval for all tests in its dermatology and ophthalmology portfolios, its TissueCypher test in gastroenterology, and its clinical laboratories in Phoenix and Pittsburgh. The company also cited a prospective clinical validation study for the 487-gene test that it said showed patients with a JAK Inhibitor Responder Profile who received JAK inhibitor therapy had greater clinical benefit than those treated with a Th2-targeted therapy.