Following the successful Change Notification (CN) approval from the World Health Organization (WHO), Colexa Biosensor Limited, a subsidiary of Codix Group is now licensed to package a WHO Prequalified (PQ) Rapid Diagnostic Test kit at its factory in Lagos, Nigeria.
Read more: WHO-approves-packaging-and-shipping-of-a-prequalified-HIV-rapid-test-at-African-manufacturing-site
This groundbreaking approval enables Colexa Biosensor Limited to locally package the WHO Prequalified HIV Rapid Diagnostic Test (RDT), making it accessible for procurement by Nigeria and international donors and marks a significant milestone in strengthening local production capabilities and advancing Nigeria’s healthcare sector. This approval is more than just an achievement for the company, it is a leap forward for Nigeria’s healthcare ecosystem, enhancing access to high-quality In-Vitro Diagnostics (IVDs) and driving local production.
In a press statement by the Group Managing Director / Chief Executive Officer; Sammy Ogunjimi stated that, “this is not just a big win for Nigeria, but for the entire African continent, as it is the first time a WHO PQ HIV Test Kit would either be manufactured, assembled or packaged in Africa, and available for procurement”. He further affirmed that the company would continue to work in collaboration with the Federal Ministry of Health (FMOH), National Agency for the Control of AIDS (NACA), National AIDS and STDs Control Programme (NASCP), National Agency for Food and Drug Administration and Control (NAFDAC), Presidential Initiative for Unlocking the Healthcare Value Chain (PVAC), and others, to make Nigeria a hub for quality diagnostic products in Africa.
Notably, this achievement is a historic first for Africa, as the Standard Q HIV 1/2 Ab 3-Line Test becomes the first WHO Prequalified HIV RDT to secure Change Notification approval for packaging within the continent. This accomplishment underscores the commitment of Codix Group to unlocking Nigeria’s healthcare value chain and contributing to the vision of the President of the Federal Republic of Nigeria.
