The non-invasive test is designed to help clinicians select systemic therapies for patients with moderate-to-severe disease.
Castle Biosciences announced it has received assay approval from the New York State Department of Health for its AdvanceAD-Tx test. The test is a non-invasive gene expression profile designed to guide systemic therapy selection for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).
The approval was granted by the NYSDOH Clinical Laboratory Evaluation Program. New York is the only US jurisdiction that conducts a formal review of laboratory-developed tests before they can be offered to patients.
“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 release. “New York State is the only US 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.”
Molecular Profiling for Therapy Selection
AD is a chronic inflammatory skin disease affecting approximately 16.5 million adults and 9.6 million children in the US. While the treatment landscape includes T helper type 2 (Th2)-targeted biologics and Janus kinase (JAK) inhibitor therapies, selecting the most appropriate therapy for an individual remains a clinical challenge.
The AdvanceAD-Tx test uses RNA expression data from skin scraping samples, requiring no biopsy. It evaluates 487 genes across 12 inflammatory and cutaneous biology pathways to identify the immune biology driving the disease. The test classifies patients into one of two molecular profiles: a JAK Inhibitor Responder Profile or a Th2 Molecular Profile.
“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,” says Matthew Goldberg, MD, senior vice president, medical, at Castle Biosciences, in a release.
Clinical Validation Results
A prospective clinical validation study found that patients with a JAK Inhibitor Responder Profile who were treated with JAK inhibitor therapy experienced significantly greater clinical benefit compared to those treated with Th2-targeted therapy. These benefits included faster skin clearance, a greater likelihood of remaining flare-free, and improved quality of life within three months.
The test is part of a portfolio that includes dermatology, ophthalmology, and gastroenterology tests. With this latest approval, the company now has New York State Department of Health approval for all tests within its dermatology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh.
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