Industry News: Bruker launches CE-IVD marked genesig assay kit for COVID-19 detection

The partnership with Primer Design aims to distribute the Genesig CE-IVD & FDA-EUA COVID-19 qPCR kit to Europe and the U.S.

31 Mar 2020

Bruker Corporation has 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.”

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