Africa identifies priority diseases for improved diagnostic access

AFRICA—Africa CDC has announced a priority list for improving access to diagnostics for epidemic-prone diseases across the continent.

Mpox, dengue, cholera, bacterial meningitis, and measles have been identified as the first set of diseases requiring targeted diagnostic tools, based on the Target Product Profiles (TPPs) criteria. 

Dr. Noah Fongwen, Senior Technical Officer for Diagnostics Access at Africa CDC, announced that specific tests for these diseases will undergo evaluation in 2025.

This initiative, part of a pilot program by the African Medicines Regulatory Harmonisation (AMRH), aims to improve regulation of in-vitro diagnostics and better address outbreaks.

Speaking at the launch of the priority list and advocacy for in-vitro diagnostics held in Nairobi, Kenya, from November 26–29, Dr. Fongwen emphasized the need to simplify and harmonize regulatory processes. 

“Diagnostics face a fragmented and lengthy approval process across multiple countries, which can delay adoption by up to 10 years,” he explained.

He also highlighted Africa’s limited diagnostic production capacity, despite the continent’s high disease burden, stressing the importance of local manufacturing to close this gap. 

To address these challenges, Africa CDC is collaborating with the African Union Development Agency (AUDA-NEPAD), the World Health Organization (WHO), and other partners to streamline the regulation of medical devices, including in-vitro diagnostics.

The process will be operational under the African Medicines Agency (AMA) and aims to reduce duplication, speed up approvals, and improve access.  

The regulatory framework will be supported by a diagnostics advisory committee (DAC), led by Professor Hicham Oumzil from the University of Mohammed V in Morocco.

Commenting on this initiative, Professor Oumzil highlighted the importance of harmonizing regulatory systems and engaging policymakers to prioritise diseases and address existing gaps. 

Experts such as Dr. Blaise Akenji from Cameroon and Anafi Mataka from the Africa Society of Laboratory Medicine (ASLM), on their part, presented updates on diagnostics for mpox, dengue, cholera, bacterial meningitis, and measles.

They noted that limited market incentives and access to clinical samples hinder diagnostic development in Africa.

For example, cholera and measles, despite being preventable, remain significant public health challenges due to inadequate sanitation, stigma, and political factors. 

The two-year pilot program for in-vitro diagnostics regulation, running from 2025 to 2026, will evaluate technical dossiers, verify product performance, and align regulatory efforts across national authorities and health ministries.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on our WhatsApp channel for updates.