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bioMérieux: BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Obtains De Novo FDA Authorization18 March, 2021
bioMérieux 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.
MARCY L’ÉTOILE, France – March 18, 2021 –– bioMérieux, a world leader in the field of in vitro diagnostics, today 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.
About bioMérieux global response to COVID-19
bioMérieux already provides several solutions for the molecular detection of SARS-CoV-2:
- ARGENE® SARS-COV-2 R-GENE® test (EUA granted on May 6, 2020): this test relies on the real-time PCR technology and can be used with most commercially available amplification PCR-platforms. The SARS-COV-2 R-GENE® test allows many patients to be tested simultaneously and provide results in 4 to 5 hours. It has been developed and is produced in France.
- BIOFIRE® COVID-19 test (EUA granted on March 23, 2020): this test is a fully automated test that provides results from a patient sample in 45 minutes. It is suitable for use in emergency situations for critically ill patients. The BIOFIRE® COVID-19 test was developed with funding from the U.S. Department of Defense (DoD) and is produced in Utah (USA).
- BIOFIRE® Respiratory 2.1 (RP2.1) Panel (EUA granted on May 1, 2020): this new panel includes SARS-CoV-2 in addition to 21 other common respiratory pathogens and delivers results in approximately 45 minutes. This test can be run on the FILMARRAY® 2.0 and FILMARRAY® TORCH platforms. This test was developed and is produced in Utah (USA).
- EMAG® and easyMAG® : equipment and associated reagents are pivotal for the extraction of nucleic acids prior to the amplification and detection of specific gene sequences. These systems are in high demand as a means of preparing nucleic acids from clinical specimens for many SARS-CoV-2 RT-PCR tests available on the market. Reagents are produced in France, instruments in Italy.
- BIOMÉRIEUX AGILIST: software-as-a-service provides speed and agility that is essential to COVID-19 reporting. Our dynamic dashboards provide meaningful insights that help hospitals and clinicians monitor, analyze, and visualize their COVID-19 data.
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in more than 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
Reuters: BIOX.PA/Bloomberg: BIM.FP
Tel.: +33 4 78 87 51 36
Tel.: (919) 645-0782
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have not been FDA cleared or approved;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have been authorized by FDA under an EUA for use by authorized laboratories;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE® tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
- VIDAS® SARS-COV-2 tests have been authorized only for the detection of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have only been authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.