BioMérieux’s BIOFIRE Respiratory Panel 2.1 Plus with SARS-CoV-2 Receives CE Mark

BioMérieux’s (Marcy-l'Étoile, France) BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked and will be commercially available in all countries that recognize CE marking.

The BIOFIRE RP2.1plus Panel is part of BioMérieux’s 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 US FDA EUA cleared BIOFIRE RP2.1 panel and the VIDAS anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG tests. The BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) tests for 23 pathogens (19 viruses, including SARS-CoV-2, and four bacteria) which are responsible for the most frequent respiratory tract infections. The new panel 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. It also includes an assay for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) allows healthcare providers to quickly identify patients with common respiratory pathogens and differentiate those with COVID-19, using one single test. It 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.”

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