Castle Biosciences and SciBase Holding AB have announced a strategic collaboration to develop an innovative diagnostic test that can predict flares in patients with atopic dermatitis before symptoms appear. The partnership combines Castle's expertise in molecular diagnostics with SciBase's AI-powered Electrical Impedance Spectroscopy (EIS) technology, specifically the Nevisense platform.
The collaboration addresses a significant unmet medical need, as Derek Maetzold, CEO of Castle Biosciences, noted: "In the projected field of use for AD flares specifically, there could be up to 24 million patients in the United States. The majority of patients who are on maintenance treatment unfortunately experience flares and therefore, have rescue treatment plans."
Technology Platform and Development Strategy
The diagnostic test will utilize SciBase's Nevisense technology, which combines artificial intelligence with advanced EIS technology to enhance diagnostic accuracy. Built on more than 20 years of research at Karolinska Institute in Stockholm, Sweden, the platform includes both desktop and point-of-care devices designed for proactive skin health management.
"This collaboration with Castle Biosciences is exciting for SciBase," said Pia Renaudin, CEO of SciBase. "It will accelerate the use of Nevisense within the skin barrier health market. It will rapidly broaden our already existing clinical studies pipeline by increasing the number of studies, ultimately speeding up access to more effective therapies for patients with skin barrier dysfunction."
Market Territories and Financial Structure
Under the agreement, Castle Biosciences will focus on the North American market, while SciBase will handle the EU, Switzerland, United Arab Emirates, Japan, and South Korea. The financial terms include SciBase receiving a single-digit royalty percentage on Castle's gross margin and a low double-digit percentage mark-up on product sales to Castle. Additionally, SciBase will receive a milestone payment of $5 million when Castle's annual sales reach $50 million.
Castle Biosciences is making a significant investment in the partnership, subscribing to approximately $19 million worth of SciBase shares at SEK 0.40 per share as part of a directed share issue totaling approximately SEK 30 million. This investment makes Castle one of SciBase's largest shareholders.
Clinical Rationale and Market Opportunity
The collaboration targets skin barrier dysfunction, a key contributing factor to multiple dermatological conditions. According to the companies, estimates suggest that over 500 million people globally are affected by conditions where skin barrier impairment plays a central role, including atopic dermatitis (~223 million), psoriasis (~125 million), and rosacea (~400 million).
Maetzold emphasized the strategic fit: "We believe this is a good fit for us, with our existing commercial portfolio of tests in skin cancers, as well as our pipeline test in development for use in patients diagnosed with moderate-to-severe AD who are seeking systemic treatment – the majority of which are managed by the same dermatological clinician."
Development Timeline and Cost Structure
While the development agreement calls for sharing of development costs, SciBase will defer its clinical development costs for the initial atopic dermatitis indication, with reimbursement coming from future royalty and milestone payments. The companies plan to jointly explore and develop various clinical indications related to dermatologic diseases beyond the initial atopic dermatitis focus.
The partnership represents Castle's expansion into the dermatologic diagnostic space, building on its existing portfolio of tests for skin cancers, Barrett's esophagus, and uveal melanoma. For SciBase, the collaboration provides access to Castle's established commercial infrastructure and expertise in bringing diagnostic tests to market in North America.
