Local test manufacture will boost climate resilience

From the newsletter

A Nigerian health technology company, Codix Bio, will begin manufacturing rapid diagnostic tests (RDTs) following a technology transfer from the global in-vitro diagnostics firm, SD Biosensor. This development comes after Codix Bio signed a sublicensing agreement with the Medicines Patent Pool, under the auspices of the World Health Organization.

• RDTs are field-based epidemiological data-gathering tools that can enhance the resilience of communities to weather and climate-related health emergencies. When information is integrated and presented in an actionable manner, it becomes invaluable for proactive decision-makers.

• In Africa, local manufacturing of RDTs for climate-related diseases such as malaria and cholera can significantly improve healthcare access and response capabilities. RDTs provide rapid and accurate diagnoses, which are crucial for timely treatment and outbreak control, especially in areas with limited access to traditional diagnostic methods.

More details

• The RDT technology enables rapid, equipment-free testing, providing results in under 20 minutes. Codix Bio will initially produce HIV tests, with plans for potential expansion to malaria and other diseases. This adaptable technology is suitable for addressing future health emergencies and strengthening regional pandemic response and health security.

• The sublicensing agreement is the first established under a non-exclusive licence between SD Biosensor (SDB) and Medicines Patent Pool (MPP), which was agreed upon in December 2023 as part of WHO’s COVID-19 Technology Access Pool (C-TAP). C-TAP has since transitioned into the Health Technology Access Programme (HTAP), aimed at reducing global diagnostic access gaps through local production and technology transfer.

• Codix Bio was selected after a WHO and MPP call for manufacturers from low- and middle-income countries (LMICs). With support from both organisations, Codix Bio will receive coordinated assistance in regulatory compliance, product uptake, and workforce development to address local and regional diagnostic needs.

• The agreement facilitates the diversification of global manufacturing and aims to reduce LMICs dependence on imported diagnostics. It is part of broader efforts to establish sustainable, self-reliant production capacity in Africa and improve equitable access to diagnostics. Partners like the Africa Centres for Disease Control and Prevention (Africa CDC), Unitaid and the Global Fund support this initiative. 

• The Africa CDC emphasised its alignment with the Platform for Harmonized African Health Manufacturing (PHAH), reinforcing regional strategies to strengthen diagnostic capacity and health sovereignty. Codix Bio’s production of RDTs under this agreement signals the operationalisation of HTAP and marks a turning point in Africa’s diagnostic manufacturing landscape.

Our take

• In April 2024, RDTs were deployed in Malawi to support cholera outbreak response, with over 1.2 million kits distributed to 14 high-risk countries including Ethiopia, Somalia, Zambia, and Nigeria. 

• This marked the largest global RDT deployment, aiming to enhance disease surveillance and guide effective vaccine targeting during health emergencies intensified by climate change.

• The initiative, coordinated by Gavi and partners, built on earlier pilot studies in the DRC and Niger. These studies helped shape strategies for routine RDT use in monitoring outbreaks caused or worsened by climate disruptions in communities lacking clean water and sanitation. 

• As flooding, displacement, and warming temperatures increase vulnerability to waterborne diseases like cholera, field-ready tools like RDTs help bridge gaps in access to healthcare. They ensure timely responses that save lives in climate-affected African regions.