Fujirebio Obtains Approval for Hepatitis B Rapid Test Kit in The Gambia

Fujirebio Inc. (hereinafter 'Fujirebio'), a subsidiary of Fujirebio Holdings, Inc. (President and Representative Director: Tadashi Ninomiya; Head Office: Minato-ku, Tokyo), has announced the approval of its product registration for the Hepatitis B rapid test kit 'ESPLINE HBeAg-hs' (hereinafter 'the product') in The Gambia.

This product is a POCT*1 diagnostic agent that provides rapid and high-sensitivity detection of Hepatitis B e-antigen (HBeAg), a protein produced during the replication of the Hepatitis B virus (HBV), and is used to determine treatment strategies. The product has also obtained certification*3 based on the European In Vitro Diagnostic Medical Devices Regulation (IVDR)*2.

According to the World Health Organization (WHO), the number of people chronically infected with HBV exceeded 250 million in 2022, with an estimated 12 million new infections annually*4. In The Gambia, HBV infection is reportedly widespread*5, and the country is actively working on the prevention, diagnosis, and treatment of Hepatitis B with support from the WHO and other organizations. In this context, Fujirebio, as part of the MHLW's project for international expansion of medical technology*6, has been working with the Gambian Ministry of Health and others to build a healthcare system for preventing mother-to-child transmission of Hepatitis B, leading to this product registration.

The Fujirebio Group will continue to accelerate its contributions to global health and further address issues such as improving healthcare access.

*1 Short for Point of Care Testing. *2 Regulation (EU) 2017/746, which applies when selling in vitro diagnostic medical devices in the EU market. Applicable since May 2022. *3 Required for selling products in the EU; this certification allows the display of the CE mark compliant with IVDR. *4 WHO: Hepatitis B *5 M. Camara et al; Prevalence of hepatitis B infection in the Gambian population: A narrative review of recent developments; Preventive Medicine Reports 36 (2023) 102401 *6 Fiscal Year 2025 project for the international expansion of medical technology, commissioned by the Ministry of Health, Labour and Welfare and implemented by the National Institute of Health Crisis Management.