WHO and the Medicines Patent Pool (MPP) announce a license agreement with SD Biosensor Inc., a global in-vitro diagnostic company, to provide sublicensees with the right, know-how and material to manufacture SDB’s rapid diagnostic testing (RDT) technology. The transparent, non-exclusive license agreement, negotiated under the auspices of the COVID-19 Technology Access Pool (C-TAP), represents an important milestone in the evolution of the C-TAP initiative as it enables the manufacture of diagnostics for COVID-19 as well as other diseases such as HIV, malaria and syphilis.
The license agreement is significant for a number of reasons:
- The technology offered through the license is ideal for low and middle-income countries as it is easy to use, with no equipment requirements and has high sensitivity. Furthermore, a number of the company’s RDTs are Prequalified and Emergency Use Listed by WHO
- The broad scope of the license – including but not limited to COVID-19 – increases both its public health value and the anticipated benefit to sublicensed manufacturers in realizing greater market opportunities and financial sustainability in the inter-pandemic period
- The comprehensive know-how and support planned for sublicensed manufacturers under a phased technology transfer plan is designed to develop manufacturing capabilities of LMIC manufacturers so they may achieve quality production at competitive prices – often the difference between success and failure.
- The enhanced ability of prospective African-based sublicensees to take advantage of the license can help increase local and regional production of RDTs, building on the August 2023 last year on accelerating the manufacturing of RDTs on the African continent, initially focusing on HIV RDTs – with the support of WHO.
The technology transfer support made possible through this agreement aligns well with the objectives of WHA Resolution 76.5 on strengthening diagnostics capacity which urges countries to commit resources to invest in research and product development and to promote local production capacity for diagnostics, particularly in developing countries. Access to diagnostics that facilitate test and treatment strategies needed to manage disease remains a core priority of WHO and its partners.
Dr Yukiko Nakatani, Assistant Director-General, Access to Medicines and Health Products, said “WHO appreciates the willingness demonstrated by SD Biosensor to share its RDT technology under the C-TAP platform, and for the support it will provide sublicensees. The license serves as a model for how the C-TAP mechanism can move beyond COVID-19 to also address other public health needs. This license reinforces WHO’s commitment to technology transfer and to promoting the need for greater local manufacturing that will benefit all patients, everywhere.”
Charles Gore, Executive Director of the Medicines Patent Pool, said “This non-exclusive, royalty-free license aims to increase local and regional production and fits firmly within MPP’s strategic goals. Rapid, sensitive diagnostics are essential for access to treatment, and what is exciting about this antigen test is that it can go further than just COVID-19 diagnosis with SD Biosensor also providing the relevant material and know-how to achieve this. We look forward to working with SD Biosensor and new partners.”
Hyo-Keun Lee, Vice Chairman of SD Biosensor Inc., said, “It’s a great pleasure to share SD Biosensor’s distinctive RDT technology with LMIC through the C-TAP platform. The transfer of RDT technology can be applied not only to COVID-19 products but also to the production of RDT products diagnosing various diseases, including HIV and malaria. Therefore, it is expected that, in the event of a disease outbreak, a rapid response can be achieved using the SD Biosensor’s RDT technology in the African continent. Additionally, there is an expectation that producing these products locally in Africa will enhance production efficiency and contribute to improving health value in Africa”.
An August 2023 emphasized the need for partnership to accelerate the manufacturing of health products in Africa, with HIV rapid diagnostic tests (RDTs) as the initial focused product category. Along with WHO, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. President’s Emergency Plan for AIDS Relief and Unitaid are partnering to pilot an open Expert Review Panel for Diagnostic Products calling for Expressions of Interest for African HIV RDT manufacturers to accelerate the availability of quality assured RDTs in Africa.
About the technology
The COVID-19 antigen test is a rapid chromatographic immunoassay for qualitative detection of proteins specific to a particular pathogen. Its platform technology allows further application into communicable pathogens beyond COVID-19, such as for HIV, malaria and syphilis. Predominantly diseases of poverty and marginalization, accurate diagnostics are a significant part of their management. Additionally, COVID-19 continues to be a burden on public health systems.
About C-TAP
WHO is in parallel announcing the design of a new business model to succeed C-TAP, a platform launched in May 2020 to encourage developers of COVID-19 therapeutics, diagnostics, vaccines and other health products, as well as building block technologies, to voluntarily share their intellectual property, knowledge, and data to accelerate technological innovation and expand global production capacity and health security. The new model – the Health Technology Access Pool or HTAP – builds on the foundation, expertise and experience developed by C-TAP, incorporating structural, process and other improvements that will enable the new model to effectively promote access to priority health technologies.
This license extends the access opportunities created by the C-TAP’s multilateral technology-sharing mechanism beyond COVID to other public health diseases as well, aligned with the design of the new business model.
A call for applications will be launched shortly.
