Press Release

[Daejeon, Republic of Korea – November 18, 2020] On November 11th, Bioneer received CE-IVD marking for its newly launched molecular diagnostic kits, ‘AccuPower® RV1 Real-Time RT-PCR Kit’ and ‘AccuPower® RV1 Multiplex Kit’, that can diagnose both COVID-19 and influenza.

AccuPower® RV1 Real-Time RT-PCR Kit is customized to Bioneer’s automated molecular diagnostic system, and AccuPower® RV1 Multiplex Kit is compatible with other PCR equipment in the market.

The Bioneer’s AccuPower® RV1 kits use a single sample to detect COVD-19 (E gene, RdRp & N gene) and Influenza A/B, resulting in much faster test results than separately testing each sample.

At the early stage, symptoms of COVID-19 and Influenza are very similar yet caused by completely different viruses. Therefore, accurate and timely testing results are important to treat each disease.

There are many reports that COVID-19 viruses are mutating constantly. Although COVID-19 vaccines and treatments are ready to be launched in near future, patients cannot be diagnosed only by their symptoms. It is inevitable that PCR testing is necessary not only to diagnose the patients properly but to minimize any confusion or possible collapse in medical and quarantine systems in many countries around the world.

Bioneer is the only company in South Korea to provide a total solution to the molecular diagnostic system. The company manufactures and supplies nucleic extractor, preparation kit, Real-time PCR equipment, and PCR kits, the four major products that require in molecular testing, to over 80 countries in the world.


Bioneer's Multiplex Assay for Flu and COVID-19



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About the Multiplex Assay for Flu and COVID-19

Bioneer received CE-mark certification for the Multiplex Assay for Flu and COVID-19.

It is an in vitro diagnostic kit that helps diagnose COVID-19 & Influenza infections. The kit is able to detect 5 targets about COVID-19(E gene, RdRp & N gene) and Influenza A/B in a tube.

It leverages the company’s original patented technology Dual-HotStart™. It can detect RNA target 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 and is publicly traded at KOSDAQ since 2005.

Bioneer has developed state-of-the-art molecular biology products and technologies over the years, including oligonucleotides, thermostable polymerases, and unique dual hot starter PCR system together with DNA/RNA synthesizer, automatic nucleic acid extractor, thermal cycler and real-time PCR instruments. Bioneer’s popular MDx system ExiStation™ offers an efficient, automated, and pipetting-free system that minimizes hands-on steps from nucleic acid extraction to PCR processes. ExiStation™ is equipped with an aerosol protection system to prevent contamination and secondary infection by users and provides an accurate test result.


[Daejeon, Republic of Korea – September 25 2020] Bioneer specializing in molecular diagnostics announced that it will build a $2.4 million lab for COVID-19 diagnosis in Iraq

Bioneer signed a turn-key project contract with the Ministry of Health and Welfare of Iraq (MOHW) to set up a laboratory for COVID-19 diagnostic tests. Under this comprehensive $2.4 million contract, Bioneer will supply and set up all the equipment and kits necessary for molecular diagnosis and research.

This contract is the first joint collaboration case between the MOHW and Bioneer's advanced technology and overseas networks. As the result of comprehensive performance evaluation of equipment and kits required for the molecular diagnosis processes from leading global companies, the MOHW of Iraq selected Bioneer products.

Bioneer is the only South Korean biotech manufacturer that provides total molecular diagnostic solutions. Through vertical integration strategy, Bioneer is providing molecular diagnostics technology, instruments and kits from raw materials to final products. The deal with the MOHW of Iraq on laboratory setup and product supply assures the significance and global competitiveness of Bioneer’s products.

Bioneer closely cooperates with its partners across the globe. As a confluent result, this contract is the outcome of advanced coordination and technical activities in Iraq by Bioneer’s local partners the Al-Musaib Bridge Company and Scientific services Bureau.

Bioneer official says that "Although Bioneer has an excellent and innovative technology, our products were less familiar in Iraq till our local partners demonstrated our products to the MOHW of Iraq."

Further it was added that "Indeed, The Foundation for Innovative New Diagnostics (FIND), a strategic partner of WHO, after evaluating Bioneer’s diagnostic kits has delivered results of the highest level in both sensitivity and specificity. Therefore, the MOHW of Iraq has showed strong interest in our products and we are expecting the next contract.”

Meanwhile, “Twindemic” concerns as COVID-19 cases raise and flu season looms. In response, Bioneer has developed a kit that can diagnose both COVID-19 and flu, in order to prevent further pandemics a convergence of the flu and COVID-19. After completing clinical studies, Bioneer is expecting to obtain CE and KFDA certifications.

Bioneer is exporting diagnostic instruments and tests to more than sixty countries across the globe, including a $ 4 million contract with Qatar, a $ 9 million contract with Saudi Arabia and a $ 4 million contract with Colombia.


[Daejeon, Republic of Korea – April 29, 2020] 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.

 


[Daejeon, Republic of Korea – April 7, 2020] Bioneer (CEO Han-oh Park) specializing in molecular diagnostics announced that it has signed an agreement with Qatar Petroleum, a state-owned company, to supply $4 million worth molecular diagnostic instruments and coronavirus detection kits in Qatar.

Under the agreement, Bioneer will supply Qatar Petroleum with COVID-19 molecular diagnostic kits, nucleic acid extraction reagents and 18 molecular diagnostic instruments such as ExiPrep™ 96 Lite and Exicycler™. Supplied instruments and kits for COVID-19 molecular diagnosis will be applied in medical institutions including the Medical Services Department of Qatar Petroleum.

Bioneer provides a total solution for molecular diagnosis with its gene extraction instrument, real-time PCR instrument, extraction reagents and assays for amplifying and analyzing genes required for COVID-19 detection and diagnostics. All Bioneer’s instruments, reagents and kits are developed by the proprietary technologies in-house.

Bioneer supplies COVID-19 related diagnostic instruments and kits to various countries around the world, including a recent $1.9 million agreement to supply its molecular diagnostic system ExiStation™ and COVID-19 detection kits in Romania.

Bioneer said that “Bioneer’s molecular diagnostic system ExiStation™ is based on Real-Time PCR and RNA extraction equipment. It is equipped with an automated system and can be operated after a short-term training.”

The company added that in addition to COVID-19, Bioneer's molecular diagnostic instrument is capable of testing various infectious diseases, such as HIV, Hepatitis B, Hepatitis C, Sexually Transmitted Infections and Tuberculosis using a molecular diagnostic kit developed by the company.

 

 

About the ExiStation™ system

The ExiStation™ was developed and launched by BIONEER, and it is the automatic molecular diagnostic system composed with 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.

The ExiStation™ is an automated molecular diagnostic system, which 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 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.

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.


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