The National Agency for Food and Drug Administration and Control (NAFDAC) has registered seven rapid diagnostic product families developed by Nigerian diagnostics company Ash Biomedical Diagnostics Ltd. These registrations cover 12 Stock Keeping Units (SKUs) across four key areas of healthcare testing: HIV, malaria, hepatitis, and pregnancy. This development expands the range of locally developed testing options available in Nigeria.
The registered products include ABD HIVChek, MalChek, MalChek Plus, HepaQuik, HepaQuik Duo, PregSure, and FlaviQuik. Notably, FlaviQuik is a rapid test for Hepatitis C, and HepaQuik Duo provides dual screening for Hepatitis B and Hepatitis C using a single test. These additions provide healthcare providers and screening programs with more rapid-testing options for identifying patients who may require further medical evaluation.
NAFDAC registration provides the regulatory basis for the marketing of these products in Nigeria. However, continued quality assurance, field performance, and post-market monitoring are crucial to sustaining confidence in diagnostic products. This development aligns with efforts to strengthen local healthcare manufacturing and expand access to diagnostic services across the country.
Ash Biomedical Diagnostics Ltd. has made significant strides in the healthcare sector, with its products reaching all 36 states of Nigeria. Over the past 15 years, the company has supplied 15 million test kits through more than 66 government and institutional contracts across 27 states. Independent evaluations of the company's products have recorded 100% concordance with reference laboratory findings.
According to Chief Executive Officer and Managing Director of Ash Biomedical Diagnostics Ltd., Adetoyese Shodeinde, the NAFDAC registrations reflect years of investment in product development, quality assurance, and regulatory compliance. Shodeinde emphasized that the company's vision extends beyond producing diagnostic kits, aiming to build confidence in Nigerian healthcare manufacturing by ensuring high-quality products.
The company is constructing a diagnostics manufacturing facility in Idu, Abuja, which is expected to be commissioned in the first quarter of 2027. This facility aims to increase local production capacity and reduce dependence on imported rapid diagnostic products. The planned facility and expanding product portfolio are part of efforts to strengthen Nigeria's healthcare manufacturing capacity and support wider access to rapid diagnostic testing.
The registration of these rapid diagnostic products demonstrates that Nigerian companies can develop diagnostic products meeting the requirements of healthcare professionals and patients. This milestone highlights the potential for local healthcare manufacturing to contribute to the country's healthcare needs, with Ash Biomedical Diagnostics Ltd. at the forefront of this effort.
Key points
- NAFDAC registers seven rapid diagnostic product families for HIV, hepatitis, malaria, and pregnancy.
- Ash Biomedical Diagnostics Ltd. has supplied 15 million test kits across 27 states over the past 15 years.
- The company is set to commission a diagnostics manufacturing facility in Abuja in the first quarter of 2027.
