By Chantelle Muzanenhamo

The World Health Organization (WHO) and Medicines Patent Pool (MPP) have announced a new sublicensing agreement with Nigerian health technology company Codix Bio. This agreement allows Codix Bio to develop and manufacture rapid diagnostic tests (RDTs) using technology transferred from the global diagnostics company SD Biosensor (SDB).

The initiative aims to improve access to vital diagnostic tools by promoting local production and increasing manufacturing capacity in Africa.

The new RDT technology is designed for use in low- and middle-income countries (LMICs). It is easy to operate in health facilities without requiring additional equipment, highly sensitive, and can deliver results within 20 minutes.

 Codix Bio will initially focus on producing RDTs for HIV, but the technology can also be adapted to tests for malaria, syphilis, and other diseases. It can be quickly adjusted to respond to health emergencies and pandemics, helping to enhance health security and equity.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, stated, “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.”

 “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,” Charles Gore, Executive Director of MPP, added.

This agreement is the first result of a non-exclusive, transparent licensing deal between SDB and MPP, established in December 2023 under the WHO COVID-19 Technology Access Pool (C-TAP), now evolved into the Health Technology Access Programme (HTAP). HTAP aims to reduce the access gap in underserved regions by supporting local producers of health products through sublicensing, technology transfer, and knowledge sharing.

Hyo-Keun Lee, Vice Chairman of SD Biosensor, commented, “This sublicensing agreement with Codix Bio marks an important milestone. By coupling technology transfer with support, this initiative helps Codix Bio respond to health priorities in Nigeria and the region, and demonstrates a collaborative model for building sustainable local manufacturing capacity.”

Following an open call for LMIC-based manufacturers, Codix Bio was selected as the first sublicensee.

“This agreement is a breakthrough for local healthcare manufacturing in Africa. It underscores our commitment to contributing to pandemic preparedness and regional health security. With support from WHO and MPP, we aim to produce high-quality rapid diagnostic tests that improve access to timely diagnosis across Africa,”Sammy Ogunjimi, CEO of Codix Group, said,

HTAP will provide support in areas such as workforce development, regulatory compliance, and product adoption. It is also exploring the possibility of a second sublicensee for this technology.

Most LMICs depend heavily on importing health diagnostics. The COVID-19 pandemic highlighted the risks of reliance on imported health products, fueling efforts to build regional manufacturing capacity. Organizations like Africa CDC, the Global Fund, and Unitaid are working to improve local health product supply resilience.

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