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African Partnership Formed to Improve IVD Access

NEW YORK – The Africa Centres for Disease Control and Prevention on Friday said it has formed a partnership with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to improve continent-wide access to diagnostic testing and improve health security.

The Africa Collaborative Initiative to Advance Diagnostics will promote local manufacturing of diagnostic devices, improve testing capacity within diagnostics centers, help harmonize regulatory processes and requirements, and negotiate for those partners on the global market. The partners said harmonizing regulatory processes for in vitro diagnostics and other medical devices will be vital to the initiative's success.

"Access to quality assured IVDs remains a major challenge in Africa, significantly impacting the disease control and prevention efforts," Yenew Kebede, head of the Africa CDC Division of Laboratory Systems, said in a statement.

The African Medicines Agency is overseeing the harmonization of medical products, and the AUDA-NEPAD's African Medical Device Forum will support those harmonization efforts specific to medical devices and IVDs.

The Africa CDC will map and build capacity in laboratories that validate IVDs and establish a diagnostics advisory committee. Agency officials hosted a meeting this month where laboratory experts from across Africa were nominated to a 15-member advisory committee.

Officials from the Africa CDC and AUDA-NEPAD agreed that the next steps should also include developing a list of diagnostics for priority diseases in Africa for evaluation and regulatory approval, establishing an African system for the certification of IVDs, and promoting African Union procurement for priority diagnostics.