Castle Biosciences, Inc. (NASDAQ:CSTL), a dermatologic diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced its innovative pipeline initiative to develop a genomic test aimed at predicting systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.
Castle Biosciences has designed, developed and validated multiple genomic tests, including three dermatologic genomic tests, all of which are currently commercially available. These tests are designed to provide information for clinicians and patients to make personalized treatment decisions along the patient care continuum, including pre-diagnosis and following diagnosis, based on the biology of each patient’s disease. With the Company’s pipeline test for psoriasis, atopic dermatitis and related conditions, Castle expands its dermatology focus from cancer to include inflammatory skin disease. This pipeline initiative is expected to produce a genomic test that predicts systemic therapy response to guide therapy selection in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.
“We are in an industry-leading position, as the only diagnostic company with a suite of dermatologic gene expression profile tests,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We have demonstrated our ability to successfully develop, validate and bring to market clinically actionable, innovative tests. We start by identifying dermatologic diseases with high unmet clinical need. We then use the gene expression profile of an individual patient’s biology in an effort to develop gene expression profile tests designed to assist clinicians and their patients by better informing treatment to optimize health outcomes and reduce health care costs.
“We are excited to expand our pipeline beyond cancer to other dermatologic diseases that significantly impact patients’ lives and have unanswered clinical questions. We are working with several leading experts in inflammatory skin diseases to develop a test that can predict a patient’s response to therapy for patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Our goal is to shift systemic therapy selection such that the appropriate therapy is selected the first time. This goal is clinically and economically important, as the burden of cost for today’s therapies are front loaded, and a significant amount is incurred within the first three months of treatment. If our test is able to guide therapy selection, based on the patient’s own disease biology, we believe we can help direct therapy selection decisions to start patients on potentially the most effective treatment sooner, while reducing the likelihood of a patient discontinuing or switching therapies, possibly resulting in a better utilization of healthcare resources.
“Based upon our development and validation timelines, we believe that we can launch this pipeline test by the end of 2025, utilizing our well-established dermatologic sales channels, adding approximately $1.9 billion to our current estimated U.S. total addressable market.”
Castle has initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test. We expect to recruit approximately 50 participating centers from across the U.S.