Castle Biosciences has announced preliminary findings from its ongoing study of a diagnostic test for atopic dermatitis (AD). The test is designed to predict which patients with moderate-to-severe AD are most likely to experience a significant response to targeted therapies, potentially transforming the treatment paradigm for this chronic condition.
The investigational test analyzes gene expression patterns to identify the specific immune pathways driving an individual's AD. This precision medicine approach aims to move away from the current "trial-and-error" method of prescribing systemic therapies, which often leads to treatment discontinuation and persistent disease burden.
The study has enrolled over 1,100 subjects across 39 clinical sites to validate the test's ability to predict a 'super response,' defined as a 90% or greater reduction in disease severity as measured by the Eczema Area and Severity Index (EASI) score within three months of initiating targeted therapy.
"It is estimated that there are more than six million patients diagnosed with moderate-to-severe AD in the US seeking treatment annually, and approximately 760,000 of these patients seek systemic treatment," said Derek Maetzold, president and CEO of Castle Biosciences. He further noted that the current trial-and-error approach results in approximately 25% of patients discontinuing their initial systemic therapy, while about 50% of patients who stay on their initial therapy still have indicators of persistent disease burden.
The company anticipates launching the test by the end of next year. Castle Biosciences is also developing a strategy for test launch, including determining the reimbursement pathway.
If successful, this test could significantly improve patient outcomes by ensuring that individuals receive the most appropriate and effective treatment from the outset. This would not only alleviate patient suffering but also reduce healthcare costs associated with ineffective treatments and disease management.
