BIOFIRE® Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked

15 July, 2020

bioMérieux announced the CE marking of BIOFIRE® Respiratory Panel 2.1 plus (RP2.1plus) tests for detection of 23 pathogens, including SARS-CoV-2.

Marcy l’Étoile, France – July 15, 2020 bioMérieux, 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 BIOFIRE® Respiratory 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 BIOFIRE® Respiratory 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 BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH 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 BIOFIRE® RP2.1plus Panel is part of a suite of products in response to the COVID - 19 pandemic. The ARGENE® SARS-CoV-2 R-GENE® was launched in March 2020, followed by the U.S. FDA EUA cleared BIOFIRE® RP2.1 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.


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
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