BIONEER CORPORATION

Bioneer specializing in molecular diagnostics announced that it will supply $5.7 million worth of COVID-19 related products to Saudi Arabia.

Bioneer through High Standard Medical Inc. will distribute COVID-19 related instruments and kits to National Unified Procurement Company, State Enterprise Aramco, and King Fahd Medical Research Centre.

Since obtaining export approval on March 31, Bioneer has been supplying COVID-19 related products to 47 countries, including a $ 1.9 million contract with Romania and a $ 4 million contract with Qatar.

Bioneer is the only South Korean company that provides a total solution for molecular diagnosis with various gene extraction instrument, real-time PCR instrument, three types of extraction reagents and two types of assays for amplifying and analyzing genes required for COVID-19 detection and diagnostics.

Bioneer’s molecular diagnostic system ExiStation™ is an efficient automated and pipetting-free system, which can prevent cross-contamination and human errors. ExiStation ™ can be used for various disease tests. After COVID-19 pandemic, it is expected to create a new market by supplying more than 40 types of molecular diagnostic products, including AIDS, Hepatitis B, Hepatitis C, Sexually Transmitted Diseases and Tuberculosis.

ExiStation™ is the only system in Asia where HIV-1, HBV and HCV virus quantitative test kits have been certified for European CE-IVD and List A.

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About the ExiStation™ system

The ExiStation™ was developed and launched by BIONEER, and it is an automatic molecular diagnostic system composed of a nucleic acid extractor, ExiPrep™ and real-time PCR, Exicycler™.

Bioneer is the first and only company in Asia to receive CE-IVD, List A certification for HIV-1, HBV, and HCV assays with ExiStation™, which was based on the results of comparative clinical trials with Roche’s COBAS 8800 system.

Automated molecular diagnostic system ExiStation™ can reduce the error of the inspector and derive quick and accurate test results. The system can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of tests.

About the COVID-19 test kit

Bioneer received CE-mark certification for ‘AccuPower^® COVID-19 Real-Time RT-PCR Kit’ and ‘AccuPower^® SARS-CoV-2 Real-Time RT-PCR Kit’.

It leverages the company’s original patented technology Dual-HotStart™. It can detect RNA targets from clinical samples with high sensitivity and specificity through eliminating non-specific synthesis and amplification.

About BIONEER Corporation

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

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

In 2020, BIONEER received its third CE-IVD, List A mark for HBV diagnosis kit and its HCV diagnosis kit was registered on the purchase list of Global Fund.