WHO, MPP partner with Nigerian firm for local manufacturing of rapid diagnostic tests in Africa 

In a statement released on Friday, WHO said the agreement aims to advance equitable access to vital diagnostic tools through local production, thereby expanding manufacturing capacity across the African region.

The deal involves technology transfer from a global in-vitro diagnostics company, SD Biosensor (SDB), to Codix Bio.

The RDT technology, developed by SDB, is particularly suitable for low- and middle-income countries (LMICs) because it requires no additional equipment, is easy to use in routine health settings, and delivers 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.

Dr Yukiko Nakatani, WHO Assistant Director-General, Access to Medicines and Health Products, said Sublicensing SDB’s RDT technology marks a major milestone in strengthening manufacturing capabilities in regions where they are needed most.

“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,” Dr. Nakatani said.

In a similar vein, Charles Gore, Executive Director of the Medicines Patent Pool, said, “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 to 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,” he said.

According to the statement, 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.

Since then, C-TAP has 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.

Hyo-Keun Lee, Vice Chairman of SD Biosensor, Inc., said, 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 but also demonstrates a collaborative model for building sustainable and self-reliant local manufacturing capacity.”  

Lee further emphasized, “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.” 

Lee further emphasized, “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.

Sammy Ogunjimi, Group Managing Director/CEO of Codix Group, said, “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. 

“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,” Ogunjimi emphasized.

HTAP – the Health Technology Access Programme 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.