The National Agency for Food and Drug Administration and Control (NAFDAC) has approved seven rapid diagnostic product families developed by Nigerian healthcare company Ash Biomedical Diagnostics Limited, expanding the range of locally produced testing solutions available in the country.
The approval covers 12 Stock Keeping Units (SKUs) designed for the rapid detection of conditions including HIV, malaria, hepatitis and pregnancy, marking a significant milestone for local medical diagnostics manufacturing.
Among the newly registered products are FlaviQuik, a rapid test kit for Hepatitis C screening, and HepaQuik Duo, a dual diagnostic product developed for the simultaneous detection of Hepatitis B and Hepatitis C infections.
According to the company, the approvals are the result of years of research, product development and quality assurance aimed at increasing access to reliable diagnostic tools while reducing dependence on imported testing kits.
Chief Executive Officer of Ash Biomedical Diagnostics Limited, Adetoyese Shodeinde, described the development as a major achievement for local healthcare innovation and manufacturing.
He said the products underwent extensive evaluation before receiving regulatory approval, adding that independent assessments conducted by major laboratories recorded 100 per cent concordance with reference results.
The company noted that the newly approved diagnostic products are expected to support disease detection efforts across hospitals, laboratories, public health programmes and community healthcare centres.
Rapid diagnostic tests play a critical role in healthcare delivery by enabling faster diagnosis and treatment decisions, particularly in areas where access to sophisticated laboratory facilities may be limited.
Over the past 15 years, Ash Biomedical has supplied approximately 15 million diagnostic test kits through government-supported programmes and contracts across 27 states of the federation.
The company said it is also expanding its production capacity through the construction of a new manufacturing facility in Idu, Abuja.
The facility, which is expected to be commissioned in the first quarter of 2027, is projected to significantly increase local production of diagnostic products and strengthen Nigeria’s healthcare manufacturing sector.
Industry stakeholders have increasingly advocated greater investment in local pharmaceutical and medical device production as part of efforts to improve healthcare security and reduce dependence on imported medical supplies.
The latest approvals by NAFDAC are expected to further support those efforts by encouraging innovation and expanding the availability of locally manufactured healthcare products.
