Press Releases
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.