Bruker Announces Launch of CE-IVD Marked genesig® Assay Kit for the Detection of the SARS-CoV-2 Virus

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.

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Tuesday, March 24, 2020
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Research, Other Health, Pharmaceutical, Technology, Medical devices, Infectious diseases, Genetics, Science, Nanotechnology, Biotechnology, Medical Supplies, Health, Other Science, Natural sciences, Laboratory techniques, Physical sciences, Chemistry, Molecular biology, Biotechnology, In Saudi Arabia, Real-time polymerase chain reaction, Middle East respiratory syndrome-related coronavirus, Assay, Bruker, Polymerase chain reaction, Bruker-Hain Diagnostics, Bruker Corporation
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BRUKER-HAIN DIAGNOSTICS, BRUKER CORPORATION
Summary
Key Points: 
  • 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.
  • The genesig assay has been validated for respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, sputum) on commonly available laboratory thermocyclers.
  • The genesig assay is designed for very high specificity for the 2019-nCoV virus strain that is implicated in COVID-19.
  • Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, commented: Bruker is joining the fight against COVID-19.



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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