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Africa CDC, FIND Partner to Build Capacity for COVID-19 Rapid Diagnostic Tests in Africa

New partnership to prepare for rapid antigen testing in Africa

On September 11, 2022 the Foundation for Innovative New Diagnostics (FIND) and the Africa Centres for Disease Control and Prevention (Africa CDC) announced a new partnership to prepare for the introduction of new high quality antigen rapid diagnostic tests for Covid-19 over the next three years.

Fast and reliable testing has emerged as a cornerstone of the global response to the COVID-19 pandemic but has only sometimes been available to African countries during the pandemic. 

Access to diagnostics also presents a significant hurdle in the fight against Covid-19 and other diseases, including TB and malaria.

Regulatory interventions have smoothed out the supply of accurate and fast antigen tests, but it has now become necessary to build capacity to ensure a speedy rollout.

While there have always been global inequities in accessing diagnostics, these became clearer and worse during the Covid-19 pandemic, with supply chain wars and quality issues impacting heavily on the situation.

In response to the announcement Dr. John Nkengasong, Director of Africa CDC, stressed the importance of fast and accurate results so that patients can be isolated and health workers can trace close contacts, especially in low- and middle-income countries (LMICs).

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US$21-million investment in molecular diagnostic platforms

FIND chooses four firms with promising new platforms for decentralized diagnosis of COVID-19 and other illnesses.

FIND is investing US$21-million to speed the development, manufacturing and launch of affordable, multi-pathogen, molecular diagnostic platforms.

These platforms are specifically aimed at decentralized settings in low- and middle-income countries (LMICs), and will detect different respiratory pathogens, including COVID-19.  

FIND launched the request for proposals in August 2021, in the context of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, which it co-leads. 

The submission deadline was September and the successful firms announced on December 2021.

The four firms are:

The German Federal Ministry of Education and Research (BMBF) is funding the investments through KfW and other donors. 

Read the full report here

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Call to boost access to cheaper rapid diagnostic tests

Key takeaway: RDT agreements boost local manufacturing to supply millions of low-cost, high-quality tests for lower-income nations.

In July 2020 FIND and Unitaid launched a call via the Access to COVID-19 Tools Accelerator Diagnostics Pillar for expressions of interest (EOI) to speed up availability and scale up manufacturing of rapid diagnostic tests (RDTs) for COVID-19.

The EOI was geared towards increasing supply of regulatory approved, fit-for-purpose SARS-CoV-2 Ag RDTs that met WHO criteria of quality, cost and accessibility. This was particularly needed in low- and middle-income countries (LMICs).

Innovators, developers and manufacturers of RDTs and in vitro diagnostics, and LMIC-based diagnostic stakeholders, were invited to submit proposals.

Interventions included:

  • Accelerating late-stage product development and optimization
  • Facilitating technology transfer activities
  • Conducting performance evaluation studies to support regulatory submissions
  • Increasing production capacity
  • Addressing supply chain challenges
  • Strengthening local capacity for development and deployment of new tests within national testing strategies. 

Driving down prices and supporting the use of less invasive specimens to enable faster LMIC uptake were also critical. 

Over 100 applications were received, with 34 selected for review by a panel of external experts. 

A first collaboration, with Premier Medical Corporation in India, was announced in January 2021. By July that year, additional technology transfer agreements were signed with stakeholders in Africa and Latin America.

These included an agreement with DCN Dx to transfer know-how to WAMA Diagnóstica (Brazil), and with Bionote and Mologic to transfer know-how to DIATROPIX of the Institut Pasteur de Dakar (Senegal). 

There is a separate partnership between Viatris (South Africa) and Guangzhou Wondfo Biotech (China).

These agreements will lead to a dramatic increase in local manufacturing, ultimately making more than 250 million low-cost (US$2–2.50) tests available for LMICs.