BIONEER CORPORATION

Bioneer specialized in molecular diagnostic instruments announced that it has additionally received List-A CE-IVD marking for AccuPower® HCV Quantitative RT-PCR Kit which used to diagnose the Hepatitis C virus – the first List-A CE marked product is AccuPower® HIV-1 Quantitative RT-PCR Kit.

The kit, called AccuPower® HCV Quantitative RT-PCR Kit, quantifies HCV viral RNA from blood samples using Bioneer’s semi-automated real-time qPCR molecular diagnostic system, ExiStation™.

The ExiStation™ instrument became eligible for procurement by the World Health Organization (WHO) and CE marked. It can analyze 16 samples at once in a basic mode and be expandable for 32 samples or 48 samples. It can detect early infections such as HIV and TB through simultaneous diagnosis and also provides users a molecular diagnostic system without heavy procurement spending.

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV) which is blood-borne. Today, most people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs. For some people, hepatitis C is a short-term illness but for 70%–85% of people who become infected with the hepatitis C virus, it becomes a long-term, chronic infection. Chronic hepatitis C is a serious disease that can result in long-term health problems, even death. Many people might not be aware of their infection because they are not clinically ill.

There is no vaccine for hepatitis C. Therefore, it is more important to diagnose the disease early with an accurate and sensitive detection kit and have a proper medical treatment.

Bioneer said, “it is a pleasure that this additional certification can prove that Bioneer is a leader in molecular diagnostic instrument market in Asian area with the fact that two products take place in CE List-A and if our new HBV kit also certified and added to the list within this year, Bioneer will be the first company which has all three detection kits certified as List-A CE in Asia” Bioneer also added “we are planning to enter into European market and international procurement market for WHO preapproval so we can expect to increase its sales there”

# # # 

About BIONEER Corporation

Established in 1992, BIONEER is the first Korean biotechnology company with the aim of the complete localization of genetic technology.

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, its HIV diagnosis kit became the first in Asia to be in CE-IVD, LIST A, and afterward, in 2019, it was registered on the purchase list of international non-profit financing organization, Global Fund.