Press Release

[Daejeon, Republic of Korea - October 29, 2019] 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”



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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.

[Daejeon, Republic of Korea - February 8, 2019] Bioneer announced that it has become the first South Korean company to register the HIV-1 Quantitative RT-PCR Kit in the Global Fund purchase list. Furthermore, it obtains the approval of the Korea Food and Drug Administration (KFDA).

On January 29, Bioneer received the KFDA approval for its AccuPower® HIV-1 Quantitative RT-PCR Kit (HIV-1 Kit). Also, on January 31 Bioneer’s HIV-1 Kit and its molecular diagnostic system ExiStation™ were registered on the Global Fund purchase list together.

The global HIV diagnostics market is expected to grow at an average annual rate of 10.5% from 2016 to 2021, with the market expanding from $23.5 billion in 2016 to $38 billion in 2021. According to the KCDC (Center for Disease Control & Prevention, Korea), the number of AIDS patients in Korea was 12,320, with 1,191 new patients reported in 2017 alone.

Bioneer's HIV-1 Kit received the CE-IVD, List A (European In-Vitro Diagnostics Certification) in October last year, and currently is in the process for WHO PQ (Prequalification) application, whilst participating in the public bidding of the other international aid agencies. In addition, with the KFDA approval, Bioneer is negotiating to provide its technology not only in Korea but also in Southeast Asia, including Vietnam, Thailand, and Indonesia in the first half of this year. The HIV testing market in Southeast Asia is estimated at $ 300 million in 2019.

Bioneer official said that "molecular diagnostic products developed and produced from raw materials to equipment by using its patented technology are well recognized overseas". It was further added that "Bioneer products in terms of quality and price are competitive with other similar products of global companies in both local and international markets.”


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About The Global Fund fights AIDS, Tuberculosis and Malaria

A form of a public-private partnership with joint donors and beneficiaries from governments, international organizations, NGOs and the private sector.

Funding for the eradication of AIDS, tuberculosis, and malaria, which is a poverty-causing disease in developing countries. Since its establishment in 2002, nearly $39 billion has been spent on three major disease-related programs in more than 150 countries.


About WHO Recommendations for the Treatment of AIDS 

In order to check the progress after treatment with HIV antiviral agents, patients with AIDS need to check the amount of HIV-1 virus in the blood at least twice a year by HIV-1 virus quantitative testing using real-time PCR technology.

[Daejeon, Republic of Korea – October 8, 2018] Bioneer Corporation (CEO: Han-oh Park) announced on October 5th that AccuPower® HIV-1 Quantitative RT-PCR Kit (hereinafter referred to as "HIV-1 Quantitative Analysis Kit") has obtained European In-Vitro Diagnostic Reagent certification the List-A CE-IVD marking from TUV Rheinland (notified body) in Germany. HIV-1 Quantitative Analysis Kit is a quantitative analysis kit for HIV in blood for the treatment of patients with AIDS

Now, Bioneer has become the first molecular diagnostics company in Asia to receive the European certification for HIV-1 Quantitative Analysis Kit.

This is a WHO recommendation to monitor the HIV-1 virus in infected patients by using the real-time quantitative PCR. Patients who receive treatment with antiretroviral drugs are required to check the amount of HIV-1 virus in the blood more than twice a year. The demand for such kits is very high as its usage is increasing.

According to the market analysis report, all around the world HIV diagnostic market is expected to grow at an annual average rate of 10.5% from 2016 to 2021, and the market size will expand from $23.5 billion to $ 38 billion.

HIV-1 Quantitative Analysis Kit is used in ExiStation™. This unique molecular diagnostic system successfully completed a comparative clinical trial in 2016 against COBAS 8800 and COBAS HIV-1 quantitative assay kit from Roche in France. In October 2018, this kit received the European In-Vitro Diagnostics Certification.

HIV-1 Quantitative Analysis Kit was certified based on the original patents of Bioneer. It is applied with Dual Hot-Start™ patented technology that enables detection of a minimum amount of HIV virus, and AccuPower® patented technology that increases the stability of the diagnostic reagents.

The ExiStation™ was developed and launched by Bioneer in 2008 when a deadly new influenza virus epidemic broke out. ExiStation™ can analyze 16 samples at once in a basic mode, it can be expanded for 32 samples or 48 samples. ExiStation™ is a financially efficient molecular diagnostic system and provides advantages for application including in the least-developed countries. ExiStation™ is easy to operate and its entire process is fully automated once samples are loaded in.

CE marking expands ExiStation™ access to all Asian, African, Latin American as well as the European markets. Also, Bioneer is now eligible to apply for the WHO PQ and Global Fund support projects and can participate in the public bidding of the international aid organizations. Therefore, Bioneer is going to expand its activities across the globe. Bioneer expects a significant increase of its great contribution to the realization of a healthy society in the following years.

Bioneer said that "our molecular diagnostic system and kit are proved to be competitive to those of global leading companies” and that it "produces raw materials and instruments all in house.”

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About BIONEER Corporation

Bioneer is the first Korean biotech company founded in 1992 with the goal of 'perfecting localization of gene technology'. Based on our core values of Innovation, Value, and Discovery, we have contributed to the construction of infrastructures for the genome revolution era of the 21st century through constant R&D and supply of state-of-art reagents and instruments essential for gene studies.

Bioneer has acquired advanced technologies, secured technologies with patents, equipped with world-class production facilities and research infrastructure. This provides a wide range of products and services with excellent quality and differentiation. We are expanding our business spectrum by developing next-generation molecular diagnostics and intractable disease treatment based on technology accumulated in genetic research products.

As a leader in biotechnology, Bioneer continues to challenge itself to become a global healthcare company that can overcome existing limitations and contributes to the health of mankind in a rapidly changing era.


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