Policy & Regulation
Bruker Launches CE-IVD Marked Genesig Assay Kit for the Detection of the SARS-CoV-2 Virus
25 March 2020 - - Germany-based instruments and diagnostic solutions provider Bruker Corp. (NASDAQ: BRKR) has inked a distribution agreement with Primer Design Ltd, 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, the company said.

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.

Bruker-Hain Diagnostics is focused on Molecular Diagnostics products within Bruker´s Microbiology and Diagnostics business.

Hain Lifescience GmbH is the legal manufacturer of the Fluorocycler XT, MTBDR 2.0 assay and of GXT nucleic acid preparation kits.

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.
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