bioMérieux receives IVDR Class D CE marking for BIOFIRE Respiratory 2.1 plus Panel & BIOFIRE FILMARRAY Pneumonia plus Panel

bioMérieux has announced that its BIOFIRE^® Respiratory 2.1 plus (RP2.1plus) Panel and BIOFIRE^® FILMARRAY^® Pneumonia plus (PNplus) Panel have received CE marking under the IVDR* as Class D in vitro diagnostic devices, the highest risk classification under the regulation.

The classification is driven by the inclusion of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) on both test menus. The continued inclusion of MERS-CoV in syndromic respiratory testing supports outbreak preparedness efforts by enabling clinicians to rapidly identify or rule out this high-consequence pathogen alongside a broad range of more commonly circulating respiratory agents from a single patient sample.

The BIOFIRE^® RP2.1plus Panel provides broad syndromic testing for upper respiratory infections¹ in about 45 minutes while the BIOFIRE^® FILMARRAY^® PNplus Panel supports the diagnosis of lower respiratory tract infections by detecting a wide range of bacterial and viral pathogens as well as key antimicrobial resistance markers² in about 1 hour. Both panels deliver actionable results that can help clinicians make informed decisions earlier in the patient's care pathway.

The IVDR Class D classification in the European Union (EU) is subject to the most rigorous regulatory requirements. It is reserved for tests intended to detect pathogens that pose a high risk to public health, ensuring the highest level of confidence in test performance, quality, and reliability. Obtaining this certification represents a significant achievement for bioMérieux, and for the entire European diagnostic market.

The newly IVDR certified panels will begin to be available on the European market early next year. In the meantime, laboratories will continue to receive BIOFIRE^® RP2.1plus and BIOFIRE^® FILMARRAY^® PNplus panels without disruption, even as regulatory requirements evolve with consistent performance and reliability, since there have been no modifications to product design or intended purpose.

* In Vitro Diagnostic Regulation, in force in the European Union.

References

1. Viruses: Adenovirus Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, MERS-CoV, SARS-CoV-2, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza A virus A/H1, Influenza A virus A/H3, Influenza A virus A/H1-2009, Influenza B virus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory syncytial virus. Bacteria: Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae.

2. Viruses: Adenovirus, Coronavirus, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza B virus, Middle East respiratory syndrome coronavirus (MERS-CoV), Parainfluenza virus, Respiratory syncytial virus. Bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
Antimicrobial Resistance Genes: Carbapenemases, ESBL, Methicillin Resistance.

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