BIOFIRE Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 obtains de novo FDA authorization
18 Mar 2021
BioMérieux has announced that BioFire Diagnostics, its subsidiary specialized in molecular syndromic infectious disease testing, has received U.S. Food and Drug Administration (FDA) de novo authorization for the BIOFIRE® RP2.1 Panel.
This 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 is the first SARS-CoV-2 diagnostic test of any kind that has been granted De Novo status by U.S. FDA, having gone through the normal U.S. FDA review pathway outside of the Emergency Use Authorization (EUA) track.
This De Novo authorization will be concurrent with the revocation of the U.S. FDA EUA that was obtained on May 1st, 2020 for this panel. The BIOFIRE® RP2.1 Panel EUA and De Novo kits are identical with the exception of changes to the labeling.
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%.
Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux said: “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 U.S. FDA De Novo authorized Covid-19 test.”
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 2 minutes of sample preparation time.
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