BioMérieux BIOFIRE Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Becomes First COVID-19 Diagnostic Test to Obtain De Novo FDA Authorization

BioMérieux (Marcy-l'Étoile, France) has received US Food and Drug Administration (FDA) De Novo authorization for the BIOFIRE RP2.1 Panel, making it the first SARS-CoV-2 diagnostic test of any kind to be granted De Novo status by US FDA.

The panel allows for the detection of 22 viral and bacterial pathogens responsible for respiratory infections, including SARS-CoV-2 (the cause of COVID-19 disease). The panel was granted De Novo status by US FDA after having gone through the normal US FDA review pathway outside of the Emergency Use Authorization (EUA) track. The De Novo authorization will be concurrent with the revocation of the US FDA EUA that was obtained on May 1, 2020 for the panel. The BIOFIRE RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.

The BIOFIRE RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated BIOFIRE FILMARRAY 2.0 and BIOFIRE Torch Systems with only two minutes of sample preparation time.

The De Novo application was supported by a multicenter prospective clinical study in which the performance of the BIOFIRE RP2.1 Panel SARS-CoV-2 assay was evaluated in over 500 specimens against a combined reference of three independent molecular SARS-CoV-2 assays, each with U.S. FDA EUA designation. The BIOFIRE RP2.1 Panel SARS-CoV-2 assay demonstrated positive percent agreement (PPA) of 98.4% and negative percent agreement (NPA) of 98.9%.

“The De Novo authorization of the BIOFIRE RP2.1 Panel demonstrates how BioFire is dedicated to responding to a rapidly-evolving global pandemic with urgency and accuracy. This is the first US FDA De Novo authorized COVID-19 test,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.

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