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Bioneer Gets List-A CE Mark for HBV Kit (Feb 04, 2020)

관리자   /   2022-09-01

Bioneer announced that its AccuPower® HBV Quantitative PCR Kit for Hepatitis B virus has obtained CE-IVD, List A marking. Bioneer is the first Korean company having acquired three certifications for HIV (Human Immunodeficiency Virus), HCV (Hepatitis C virus), and HBV (Hepatitis B virus), which cover two-thirds of the world's USD 9.9 billion molecular diagnostics market.

The CE-IVD certification, according to the level of risks associated with the use of in-vitro diagnostic medical devices, is separated into four levels, with List A is being the highest level. Few global companies have CE-IVD, List A approved products, such as Roche, Hologic, and Qiagen, which account for about 60% of the infectious disease market. Especially, it is important to diagnose uncurable viruses such as AIDS, Hepatitis B, and Hepatitis C at early stages with high detection sensitivity molecular diagnosis for proper treatment.

In addition, the molecular diagnostic system ExiStation™ used in clinical trials is based on real-time PCR and gene extraction equipment, and can simultaneously diagnose Hepatitis B, Hepatitis C, HIV, Tuberculosis and Sexually Transmitted Infections. It can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of inspection, and is equipped with an automated system to reduce the error of the inspector and derive quick and accurate inspection results.

Bioneer said that “with the certification of HBV quantitative analysis kit, we have completed marking of all three major items of molecular diagnostics. Based on this, we will increase our participation in national bidding and accelerate the expansion of distributors in overseas countries such as Europe, Southeast Asia, and Africa and supporting global funds.”

Meanwhile, hepatitis B virus can cause liver disease such as chronic hepatitis, cirrhosis and liver cancer, claiming 1 million deaths every year. More than 300 million people around the world are known to have been infected.


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About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company with aim of the complete localization of genetic technology and publicly traded at KOSDAQ since 2005.

BIONEER’s multiplex molecular diagnostics kit for the ZIKA, dengue and chikungunya viruses was listed in Emergency Use Assessment and Listing (EUAL) from WHO in 2016.

In 2018, BIONEER received its first CE-IVD, List A mark for HIV diagnosis kit and afterward, it was registered on the purchase list of international non-profit financing organization, Global Fund.

In 2019, BIONEER received its second CE-IVD, List A mark for HCV diagnosis kit.



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