Bruker Announces Launch of CE-IVD Marked genesig® Assay Kit for the Detection of the SARS-CoV-2 Virus
March 24 2020 - 4:05PM
Business Wire
- Real-Time PCR kit validated for a variety of respiratory
samples types
- Validated with Bruker-Hain GenoXtract 12 DNA/ RNA extraction
system and kits
- Agreement signed with Primer Design LTD (UK), part of the
Novacyt Group, for Bruker-Hain Diagnostics distribution of CE-IVD
marked genesig® COVID-19 diagnostics kits
Bruker Corporation (Nasdaq: BRKR)
today announced a distribution agreement with Primer Design Ltd
(UK), a subsidiary of Novacyt SA, for Bruker-Hain Diagnostics to
distribute the CE-IVD-labeled genesig® real-time PCR coronavirus
(COVID-2019) assay, effective immediately. Bruker-Hain Diagnostics
has a portfolio of DNA/RNA extraction and preparation systems and
kits.
The genesig® real-time PCR Coronavirus (COVID-2019) CE-IVD assay
is validated for use on Bruker-Hain Diagnostics GenoXtract® (GXT)
automated nucleic acid extraction devices with associated
extraction kits. Shipments to Spain, France, Germany and the UK
have already started.
The genesig assay has been validated for respiratory samples
(nasopharyngeal swabs, oropharyngeal swabs, sputum) on commonly
available laboratory thermocyclers. The kit includes all necessary
reagents to produce up to 96 results in under two hours. The
genesig assay is designed for very high specificity for the
2019-nCoV virus strain that is implicated in COVID-19. The genesig®
test is CE-IVD marked and intended for in vitro diagnostic use in
Europe.
Graham Mullis, CEO of Novacyt SA, stated: “With Bruker we have
found a strong distribution partner with a Microbiology &
Diagnostics business that has significant reach into a large number
of European infectious disease laboratories. This will help to
bring our genesig test into laboratories quickly, where its
diagnostic results can help to prevent the further spreading of
COVID-19.”
Dr. Wolfgang Pusch, Executive Vice President Microbiology &
Diagnostics at Bruker Daltonics, commented: “Bruker is joining the
fight against COVID-19. In combination with our validated
GenoXtract (GXT) products for nucleic acid extraction, we
now offer a solution for preparation and detection of the
SARS-CoV-2 virus. We have also seen accelerated orders of our
MALDI Biotyper systems from Chinese CDC laboratories, e.g.
to rule in or out bacterial infections in severe respiratory
disease.”
About Bruker-Hain Diagnostics
Bruker-Hain Diagnostics is focused on Molecular Diagnostics
(MDx) products within Bruker´s Microbiology & Diagnostics
business. Hain Lifescience GmbH is the legal manufacturer of the
Fluorocycler XT, MTBDR 2.0 assay and of GXT nucleic acid
preparation kits. For more information, please visit,
www.hain-lifescience.de.
About Bruker Corporation (Nasdaq: BRKR)
Bruker is enabling scientists to make breakthrough discoveries
and develop new applications that improve the quality of human
life. Bruker’s high-performance scientific instruments and
high-value analytical and diagnostic solutions enable scientists to
explore life and materials at molecular, cellular and microscopic
levels. In close cooperation with our customers, Bruker is enabling
innovation, improved productivity and customer success in life
science molecular research, in applied and pharma applications, in
microscopy and nanoanalysis, and in industrial applications, as
well as in cell biology, preclinical imaging, clinical phenomics
and proteomics research and clinical microbiology. For more
information, please visit: www.bruker.com.
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Investor Contact: Miroslava Minkova Director of Investor
Relations and Corporate Development T: +1 (978) 663–3660, ext. 1479
E: miroslava.minkova@bruker.com
Contact for Media and Customers: Philip Perry Bruker
Daltonics T: +49-172-313-7216 E: Philip.Perry@bruker.com
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