Call for Expression of Interest: Test Developers to inform about Commercialized and in-Development Diagnostic Tests for Africa CDC Priority Diseases

BACKGROUND
The Africa Centres for Disease Control and Prevention (Africa CDC) is the African Union’s autonomous health agency with the mandate to promote the prevention and control of diseases in Africa. The agency’s mission is to strengthen the capabilities of Africa’s public health institutions to detect and respond quickly and effectively to disease outbreaks and other health burdens through an integrated network of continent-wide preparedness and response, surveillance, laboratory,
and research programs.
To accelerate access to diagnostics in the continent, Africa CDC is working with partners to streamline regional and continental harmonization of the regulatory processes for medical devices including In-Vitro Diagnostics (IVDs). To do this, Africa CDC is working with the Africa Union Development Agency-NEPAD’s AMRH programme through the continental technical committee responsible for supporting the regulatory framework for medical devices and In-Vitro Diagnostics, the Africa Medical Device Forum (AMDF), to close the gap between the laboratory and regulatory work streams for IVDs. A Diagnostics Advisory Committee (DAC) has been formed as a mechanism to provide this support.

An African mechanism has been devised to accelerate access to diagnostics for diseases of high importance to the African continent. Africa CDC has published its priority list of diseases. The DAC will work to facilitate the development, evaluation, and implementation of accessible, quality-assured in-vitro diagnostics for these priority diseases through information sharing and advocacy. The DAC will support Africa CDC with this EOI to identify manufacturers commercializing or developing diagnostic assays for priority diseases. The evaluation of selected priority assays will generate high-quality data that can be used by National Regulatory Authorities (NRAs) for product registration. This registration will be facilitated through the AMDF and the AMRH programme.
Africa CDC priority diseases can be accessed using this link: https://africacdc.org/download/risk-ranking-and-prioritization-of-epidemic-prone-diseases/