bioMérieux Receives Emergency Use Authorization for BIOFIRE® COVID-19 Test
24 Março 2020 - 3:00AM
Business Wire
Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro
diagnostics, today announced that its subsidiary, BioFire Defense,
has received Emergency Use Authorization by the U.S. Food and Drug
Administration of its BIOFIRE® COVID-19 test for use in CLIA
moderate and high complexity clinical laboratories to detect
SARS-CoV-2.
The BIOFIRE® COVID-19 test detects SARS-CoV-2 in approximately
45 minutes from a nasopharyngeal swab in transport media. This test
runs on the fully automated FILMARRAY® 2.0 and FILMARRAY® TORCH
platforms and is extremely easy to use, therefore requiring minimal
training and skills in molecular biology.
BIOFIRE® COVID-19 was developed with funding from the U.S.
Department of Defense (DoD) by leveraging an existing contract
agreement with BioFire Defense. This is the second of three tests
being developed for diagnostic use as part of bioMérieux’s
strategic response to the COVID-19 pandemic.
“The rapid development of this test is a combined result of the
extensive effort and dedication of our employees, the assistance of
our partner Midwest Research Institute Global, and the confidence
entrusted to us by the U.S. Department of Defense,” said Bob
Lollini, CEO of BioFire Defense.
bioMérieux is currently making every effort to scale up supply
of the BIOFIRE® COVID-19 test at multiple production facilities in
Salt Lake City (Utah, USA). The initial test kits are committed to
the DoD for redistribution. Test kits will be available for
commercial distribution in the United States under the EUA as well
as internationally where regulatory approval allows. bioMérieux
expects to have maximum production capability within a few weeks to
address the needs of the thousands of labs and healthcare
professionals using one of the nearly 11 000 BIOFIRE® systems
worldwide.
“In the face of this unprecedented global health crisis,
bioMérieux is now launching a second diagnostic test for the
detection of SARS-CoV2. True to our commitment to public health we
are making every effort to provide a comprehensive diagnostic
approach that meets the highest performance and quality standards
to help physicians mount an effective response to the ongoing
COVID-19 pandemic,” said Dr. Mark Miller, Executive Vice President
and Chief Medical Officer of bioMérieux.
bioMérieux has also received authorization to sell the BIOFIRE®
COVID-19 test External Control Kit. This positive control material
may be used for quality control and laboratory verification of the
test.
About bioMérieux’s commitment to fight COVID-19 pandemic
bioMérieux already launched the SARS-COV-2 R-GENE® test. This
real-time PCR test running on open platforms has been validated by
the French Reference Center for respiratory infectious diseases,
highlighting its excellent performance. It is produced and
available in France and is expected to be rapidly CE-marked and
submitted to the FDA for an EUA (Emergency Use Authorization) as
well.
bioMérieux is also developing an expanded version of its
BIOFIRE® FILMARRAY® Respiratory Panel 2, which will be called the
BIOFIRE® Respiratory Panel 2.1 (RP2.1). This new panel will include
SARS-CoV-2 in addition to the 21 other common respiratory pathogens
and will deliver results in approximately 45 minutes. It will also
be available on the FILMARRAY® 2.0 and FILMARRAY® TORCH
platforms.
About Emergency Use Authorization The BIOFIRE® COVID-19
test has not been FDA cleared or approved. This test has been
authorized by FDA under an EUA for use by authorized laboratories
only for the detection of nucleic acid from SARS-CoV-2, not for any
other viruses or pathogens.
This test is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics tests for 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.
About the BIOFIRE® FILMARRAY® solution The BIOFIRE®
FILMARRAY® is an FDA-cleared and CE-marked multiplex PCR closed and
fully-automated system that integrates sample preparation,
amplification, and detection. A BIOFIRE® FILMARRAY® test requires
only two minutes of hands-on time and has a total run time of about
45 to 75 minutes, depending on the panel.
The BIOFIRE® FILMARRAY® range has the largest infectious disease
pathogen menu commercially available, composed of:
- BIOFIRE® Respiratory Panel (RP, RP2 and RP2plus), identifying
between 20 and 22 respiratory viruses and bacteria performed
directly on nasopharyngeal swabs in transport media.
- BIOFIRE® RP EZ, identifying 11 viral and 3 bacterial pathogens
associated with respiratory infections. FDA-cleared and CLIA-waived
for use in the US only.
- BIOFIRE® Pneumonia (PN) and Pneumonia plus (PNplus) Panel,
identifying 33 to 34 targets (18 bacteria, 8 to 9 viruses, 7
resistant genes to antibiotics) in sputum (including endotracheal
aspirate) and bronchoalveolar lavage (including mini-BAL). 15 of
the bacterial targets are reported with semi-quantitative
information about the abundance of organism in a given sample.
- BIOFIRE® Blood Culture Identification (BCID) Panel, identifying
27 of the most common causes of bloodstream infections and
associated antimicrobial resistances directly from positive blood
culture.
- BIOFIRE® Gastrointestinal (GI) Panel, identifying 22 of the
most common viral, bacterial, and parasitic causes of infectious
diarrhea directly from stool in Cary Blair transport media.
- BIOFIRE® Meningitis/Encephalitis (ME) Panel, identifying 14
bacterial, viral, and fungal causes of meningitis and encephalitis
directly from cerebrospinal fluid.
ABOUT BIOMÉRIEUX Pioneering Diagnostics A
world leader in the field of in vitro diagnostics for over 55
years, bioMérieux is present in 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
Corporate website: www.biomerieux.com Investor website:
www.biomerieux-finance.com
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version on businesswire.com: https://www.businesswire.com/news/home/20200323005729/en/
Investor Relations bioMérieux Sylvain Morgeau + 33
4 78 87 51 36 investor.relations@biomerieux.com
Media Relations bioMérieux Aurore Sergeant + 33 4
78 87 21 99 media@biomerieux.com
Image Sept Laurence Heilbronn + 33 1 53 70 74 64
lheilbronn@image7.fr
Claire Doligez + 33 1 53 70 74 48 cdoligez@image7.fr
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