The World Health Organization (WHO) and Medicines Patent Pool (MPP) have today announced a sublicensing agreement between MPP and a Nigerian health technology company – Codix Bio – to start development and manufacturing of rapid diagnostic tests (RDTs) using technology transferred from global in-vitro diagnostics company – SD Biosensor (SDB). This agreement will contribute to advancing equitable access to vital diagnostic tools through local production, expanding manufacturing capacity in the African Region.
The new RDT technology is especially useful for low- and middle-income countries (LMICs), as it is easy to use in health facilities without requiring additional equipment. Tests are highly sensitive and can generate results within 20 minutes. Codix Bio will initially focus on producing RDTs for HIV, but the technology can also be used for manufacturing tests for malaria and syphilis, among others. It can also be quickly adapted to other diseases, which will prove valuable during health emergencies and pandemics, contributing to improvements in health security and equity.
"Sublicensing SDB's RDT technology marks a major milestone in strengthening manufacturing capabilities in regions where they are needed most," said Dr Yukiko Nakatani, WHO Assistant Director-General, Access to Medicines and Health Products. "It can help advance global commitments made at the 2023 World Health Assembly to promote equitable access to diagnostics as a cornerstone of universal health coverage and pandemic preparedness."
"We are delighted to have signed this first sublicense agreement for RDTs with Codix Bio. Today marks a major step forward in diversifying diagnostic production and ensuring access where it is needed most," said Charles Gore, Executive Director of the Medicines Patent Pool. "It shows how voluntary licensing and coordinated technology transfer can empower manufacturers in LMICs, ultimately helping reshape global supply chains to become more equitable and resilient."
A new beginning for HTAP
This agreement is the first to come out of a non-exclusive, transparent license between SDB and MPP, which was agreed in December 2023 under the auspices of the WHO COVID-19 Technology Access Pool (C-TAP) initiative . C-TAP has since evolved as HTAP – the Health Technology Access Programme , with the goal of reducing the access gap in underserved regions and countries by empowering capable local producers of health products (tests, vaccines, treatments and medical devices) through sublicensing, technology and know-how transfer.
"The announcement of this sublicensing agreement with Codix Bio marks an important milestone in our partnership with WHO and MPP. By coupling the technology transfer with coordinated support, this initiative not only helps Codix Bio respond to health priorities in Nigeria and the region – it also demonstrates a collaborative model for building sustainable and self-reliant local manufacturing capacity," said Hyo-Keun Lee, Vice Chairman of SD Biosensor, Inc. "We are proud that our highly adaptable and reliable rapid diagnostic testing technology will contribute to strengthening regional manufacturing ecosystems and expanding equitable access to diagnostics."
After the WHO and MPP open call was announced for applications for LMIC-based manufacturers, Codix Bio was selected as the first sublicensee. "This landmark agreement is a defining moment in our journey of health-tech innovation and a breakthrough for local healthcare manufacturing in Africa. Being selected as the first sublicensee under this global initiative underscores our commitment to contribute meaningfully to pandemic preparedness and regional health security," said Sammy Ogunjimi, Group Managing Director/CEO, Codix Group. "With support from WHO and MPP, we are committed to producing high-quality, rapid diagnostic tests that can transform access to timely diagnosis, not just in Nigeria, but across the continent."
HTAP will coordinate support from across WHO and its partners, covering areas such as workforce development, regulatory compliance and product uptake. It is also continuing with evaluations for a potential second sublicensee for this technology transfer.
Most LMICs rely on importing health diagnostics. Following fragility and heavy dependence on imported health product supplies during the COVID-19 pandemic and important lessons learnt for regional health security, there is growing momentum for improving local production and supply resilience, including by institutions such as the Africa Centres for Disease Control and Prevention (Africa CDC), the Global Fund and Unitaid.
