BIONEER CORPORATION

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.”