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Bruker Announces Launch of CE-IVD Marked genesig® Assay Kit for the Detection of the SARS-CoV-2 Virus
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
About this update from Bruker Corporation
[{"type":"text","content":"\n\nReal-Time PCR kit validated for a variety of respiratory samples types\n\n\nValidated with Bruker-Hain GenoXtract 12 DNA/ RNA extraction system and kits\n\n\nAgreement 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\n\n\n NEHREN, Germany--(BUSINESS WIRE)--\n\nBruker 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.\n\n\nThe 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.\n\n\nThe 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.\n\n\nGraham 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.”\n\n\nDr. 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.”\n...