Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRERespiratory Panel 2.1 plus (RP2.1plus) tests for 23 pathogens (19 viruses, including SARS-CoV-2, and 4 bacteria) responsible for the most frequent respiratory tract infections. It will be commercially available in all countries that recognize CE marking from now on or shortly thereafter
The BIOFIRE RP2.1plus advances the existing BIOFIRERespiratory Panel 2 plus (RP2plus) by adding SARS-CoV-2 to the panel menu while maintaining an assay runtime of about 45 minutes. The BIOFIRE RP2.1plus panel also includes an assay for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). This new panel allows healthcare providers to quickly identify patients with common respiratory pathogens and differentiate those with COVID-19, using one single test. The BIOFIRE RP2.1plus runs on the fully automated BIOFIREFILMARRAY 2.0 and BIOFIRE FILMARRAYTORCH systems and is extremely easy to use.
"The availability of BIOFIRE RP2.1plus in all countries recognizing CE marking represents a global syndromic response to this unprecedented COVID-19 pandemic," said Pierre Boulud, Chief Operating Officer, Executive Vice President, Clinical Operations at bioMérieux. "With increasing reagent production capacity and an installed base of more than 14 000 BIOFIRE units throughout the world, BIOFIRE RP2.1plus will play a key role now and in the upcoming respiratory season as healthcare providers face the regular group of respiratory pathogens as well as SARS-CoV-2", he added.
The BIOFIRERP2.1plus Panel is part of a suite of products in response to the COVID 19 pandemic. The ARGENESARS-CoV-2 R-GENE was launched in March 2020, followed by the U.S. FDA EUA cleared BIOFIRERP2.1 panel and the VIDAS anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG tests. These complementary tests help meet the varying needs of bioMérieux's diverse customers and patients throughout the world.
About the BIOFIRE solution
The BIOFIRE solution is a U.S. FDA-cleared and CE-marked multiplex PCR closed and fully-automated system that integrates sample preparation, amplification, and detection. A BIOFIRE test requires only two minutes of hands-on time and has a total run time of about 45 to 75 minutes, depending on the panel.
The BIOFIRE range has the largest infectious disease pathogen menu commercially available composed of:
- BIOFIRE Respiratory Panels (RP, RP2, RP2plus, RP2.1 and RP2.1plus), identifying between 20 and 23 respiratory viruses and bacteria performed directly on nasopharyngeal swabs in transport media.
- BIOFIRE COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media.
- BIOFIRE RP EZ, identifying 11 viral and 3 bacterial pathogens associated with respiratory infections. FDA-cleared and CLIA-waived for use in the US only.
- BIOFIRE Pneumonia (PN) and Pneumonia plus (PNplus) Panels, identifying 33 to 34 targets (18 bacteria, 8 to 9 viruses, 7 resistance genes to antibiotics) in sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL). 15 of the bacterial targets are reported with semi-quantitative information about the abundance of organisms in a given sample.
- BIOFIREBlood Culture Identification 2 (BCID2), identifying 43 of the most common causes of bloodstream infections and associated antimicrobial resistances directly from positive blood culture.
- BIOFIREGastrointestinal (GI) Panel, identifying 22 of the most common viral, bacterial, and parasitic causes of infectious diarrhea directly from stool in Cary Blair transport media.
- BIOFIRE Meningitis/Encephalitis (ME) Panel, identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
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 |
Corporate website: www.biomerieux.com.
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Contacts:
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bioMérieux
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investor.relations@biomerieux.com
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bioMérieux
Aurore Sergeant
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media@biomerieux.com
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