Bioneer Receives CE Mark for Coronavirus Kits, Inks Supply Agreement in Romania (Mar 19, 2020)
관리자 / 2022-09-01
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.
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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.