Regulatory News:

bioMérieux (Paris:BIM), 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.

About the ARGENE® SARS-COV-2 R-GENE® test : As for all tests in the ARGENE® range, the SARS-COV-2 RESPI R-GENE® may be performed by any laboratory using PCR technology on commercially-available nucleic acid extraction and amplification platforms. Results are delivered in 4 to 5 hours, and a large number of patient samples may be processed simultaneously.

The entire ARGENE® range for the detection of SARS-CoV-2 is produced in France at the bioMérieux site in Verniolle (Ariège).

ABOUT BIOMÉRIEUX Pioneering Diagnostics A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2019, revenues reached €2.7 billion, with over 90% of international sales.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market. Symbol: BIM – ISIN Code: FR0013280286 Reuters: BIOX.PA/Bloomberg: BIM.FP

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