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16 DECEMBER, 2020

bioMérieux announces the CE marking of its molecular biology ARGENE® test for the simultaneous detection of SARS-CoV-2, influenza viruses A and B, and RSV and hMPV viruses

Marcy l’Etoile, France – December 16, 2020 – bioMérieux, a world leader in the field of in vitro diagnostics, has announced the expansion of its ARGENE® range for the real-time PCR (RT-PCR) detection of SARS-CoV-2: the SARS-COV-2 RESPI R-GENE® test has received CE marking and is now commercially available.

This high-throughput test, which can be used on molecular biology platforms in hospital laboratories and private laboratories, allows the simultaneous (multiplex) detection of SARS-CoV-2 and influenza viruses A and B. In addition, it includes a cellular control to check the quality of the sample, providing an important clinical advantage in the context of the pandemic and large-scale sample collection at many different sites. In a single kit, this new test comes with a second RT-PCR analysis performed from the same extraction, for the detection of two other pathogens that often circulate at the same time and are particularly implicated in respiratory diseases affecting children and seniors: RSV (human respiratory syncytial virus) and hMPV (human metapneumovirus). hMPV is more rarely included in testing panels. 


Infections caused by respiratory viruses often have similar symptoms, but patient management may differ. Multiplex tests have a key role to play with the onset of winter and the flu season. Although the circulation of flu viruses is low to date, in light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups. This makes it possible to adapt clinical management and limit the circulation of these viruses,” explained François Lacoste, Executive VP, R&D.


The SARS-COV-2 RESPI R-GENE® test will be available in Europe and in countries that recognize the CE marking.

«La symptomatologie des infections dues aux virus respiratoires est souvent semblable mais la prise en charge des patients peut être différente. Les tests multiplexés jouent un rôle primordial avec l’arrivée de l’hiver et de la saison grippale. Même si, à ce jour, les virus grippaux circulent peu, il est d’autant plus important dans le contexte de la pandémie COVID-19,d’identifier précocement d’autres pathogènes associés aux maladies respiratoires, notamment dans les groupes de population à risque afin d’adapter la prise en charge clinique et limiter la circulation de ces virus » explique François Lacoste, Directeur Exécutif, R&D.

Le test SARS-COV-2 RESPI R-GENE® sera disponible en Europe et dans les pays qui reconnaissent le marquage CE.

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