Press Release

[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.

 

 

# # #

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.


[Daejeon, Republic of Korea – March. 19, 2020] Bioneer (CEO Han-oh Park) specialized in molecular diagnostics announced that it has signed an agreement in about $1.9 million deal to supply its molecular diagnostic system ExiStation™ and coronavirus detection kits in Romania.

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

Bioneer said that it is receiving export inquiries of molecular diagnostic system and COVID-19 kit from many countries in Europe, Southeast Asia, Middle East, etc., and it is discussing the supply in full swing with CE certification.

According to the supply agreement, Bioneer distributes the ExiStation™ and COVID-19 test kits to 20 hospitals designated by the Romanian Ministry of Public Health.

Bioneer’s molecular diagnostic system ExiStation™ is based on Real-Time PCR and RNA extraction equipment. It is equipped with an automated system to reduce the error of the inspector and derive quick and accurate inspection results and it also can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of inspection.

The COVID-19 test kit, distributed together, 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 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.

 

About BIONEER Corporation

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

 


[Daejeon, Republic of Korea – Feb. 4, 2019] Bioneer announced that its AccuPower® HBV Quantitative PCR Kit for Hepatitis B virus has obtained CE-IVD, List A marking. Bioneer is the first Korean company having acquired three certifications for HIV (Human Immunodeficiency Virus), HCV (Hepatitis C virus), and HBV (Hepatitis B virus), which cover two-thirds of the world's USD 9.9 billion molecular diagnostics market.

The CE-IVD certification, according to the level of risks associated with the use of in-vitro diagnostic medical devices, is separated into four levels, with List A is being the highest level. Few global companies have CE-IVD, List A approved products, such as Roche, Hologic, and Qiagen, which account for about 60% of the infectious disease market. Especially, it is important to diagnose uncurable viruses such as AIDS, Hepatitis B, and Hepatitis C at early stages with high detection sensitivity molecular diagnosis for proper treatment.

In addition, the molecular diagnostic system ExiStation™ used in clinical trials is based on real-time PCR and gene extraction equipment, and can simultaneously diagnose Hepatitis B, Hepatitis C, HIV, Tuberculosis and Sexually Transmitted Infections. It can be expanded and configured according to the size of the laboratory, the number of specimens, and the type of inspection, and is equipped with an automated system to reduce the error of the inspector and derive quick and accurate inspection results.

Bioneer said that “with the certification of HBV quantitative analysis kit, we have completed marking of all three major items of molecular diagnostics. Based on this, we will increase our participation in national bidding and accelerate the expansion of distributors in overseas countries such as Europe, Southeast Asia, and Africa and supporting global funds.”

Meanwhile, hepatitis B virus can cause liver disease such as chronic hepatitis, cirrhosis and liver cancer, claiming 1 million deaths every year. More than 300 million people around the world are known to have been infected.

 

# # #

About BIONEER Corporation

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


First     Previous     / 2     Next     Last
Copyright© 2020 BIONEER CORPORATION. All rights reserved.