Geneva: In a groundbreaking move for African healthcare, the World Health Organization (WHO) and Medicines Patent Pool (MPP) have partnered with Nigerian health technology firm Codix Bio to bring rapid diagnostic test (RDT) production to the continent. This initiative is a critical step toward equitable access to vital diagnostic tools and strengthening regional manufacturing capacity.
This sublicensing agreement, announced today, aims at expanding local production in the African Region. This marks a pivotal step in bolstering local manufacturing and ensuring equitable access to critical diagnostic tools in low- and middle-income countries (LMICs).
The agreement enables Codix Bio to develop and manufacture rapid diagnostic tests (RDTs) using technology transferred from global in-vitro diagnostics leader SD Biosensor (SDB).
The RDT technology is particularly transformative for low- and middle-income countries (LMICs). These tests are highly sensitive, produce results within 20 minutes, and require no additional equipment, making them ideal for health facilities in resource-limited settings. Codix Bio will initially focus on producing RDTs for HIV, but the technology’s versatility allows for tests for malaria, syphilis, and other diseases. Its adaptability also makes it a powerful tool for rapid response during health emergencies and pandemics, contributing to global 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 for 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.”
Charles Gore, Executive Director of the Medicines Patent Pool, highlighted the agreement’s significance: “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. 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 Era for HTAP
This agreement is the first outcome of a non-exclusive, transparent license between SDB and MPP, established in December 2023 under the WHO’s COVID-19 Technology Access Pool (C-TAP) initiative. C-TAP has since evolved into the Health Technology Access Programme (HTAP), which seeks to reduce access gaps in underserved regions by empowering local producers of health products—tests, vaccines, treatments, and medical devices—through sublicensing, technology transfer, and know-how sharing.
Hyo-Keun Lee, Vice Chairman of SD Biosensor, Inc., emphasised the collaborative model: “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. 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.”
Following an open call by WHO and MPP 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,” said Sammy Ogunjimi, Group Managing Director/CEO of Codix Group. “Being selected as the first sublicensee under this global initiative underscores our commitment to contribute meaningfully to pandemic preparedness and regional health security. 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 provide comprehensive support to Codix Bio, covering workforce development, regulatory compliance, and product uptake, while also evaluating candidates for a potential second sublicensee for this technology transfer.
Addressing a Critical Need
The agreement addresses a longstanding challenge: most LMICs rely heavily on imported health diagnostics. The COVID-19 pandemic exposed the fragility of this dependence, underscoring the need for regional health security. Lessons learned have fueled momentum for improving local production and supply resilience, supported by institutions like the Africa Centres for Disease Control and Prevention (Africa CDC), the Global Fund, and Unitaid.
About Medicines Patent Pool (MPP)
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation dedicated to increasing access to life-saving medicines and facilitating their development for LMICs. Through its innovative business model, MPP collaborates with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines, pooling intellectual property to encourage generic manufacture and the development of new formulations.
As Codix Bio embarks on this transformative journey, Nigeria is poised to lead a diagnostic revolution in Africa, one rapid test at a time, setting a precedent for sustainable, equitable healthcare across the continent.
– global bihari bureau
