First of 3 Diagnostic Tests for SARS-CoV-2 Coronavirus Available from bioMérieux
11 Março 2020 - 3:00AM
Business Wire
Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro
diagnostics, is announcing the forthcoming launch of 3 different
tests to address the COVID-19 epidemic and to meet the different
needs of physicians and health authorities in the fight against
this emerging infectious disease.
bioMérieux has finalized the development of the SARS-COV-2
R-GENE® test. This real-time PCR test is clinically validated on
one type of respiratory specimen and will be available at the end
of March. It is expected to be rapidly CE marked and submitted to
the FDA for an EUA (Emergency Use Authorization) as well.
In parallel, a fully-automated test based on the BIOFIRE®
FILMARRAY® technology is being developed with the support of the US
Department of Defense. This test will specifically detect
SARS-CoV-2 and is designed to run on FILMARRAY® 2.0 and FILMARRAY®
TORCH platforms.
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.
These two BIOFIRE® tests will be submitted to relevant
regulatory authorities in Q2 and Q3 2020 respectively, their launch
will follow immediately after regulatory authorization or
clearance.
“In the face of the urgency of the COVID-19 epidemic, bioMérieux
is committed to provide a comprehensive diagnostic approach that
meets the highest performance and quality standards to help
physicians mount an effective response to the outbreak”, said Dr.
Mark Miller, Executive Vice President and Chief Medical Officer of
bioMérieux.
The ARGENE® SARS-COV-2 R-GENE® tests will be produced in
Verniolle (France), the BIOFIRE® SARS-CoV-2 and BIOFIRE® RP2.1
tests in Salt Lake City (USA). Both production sites benefit from
an extensive expertise in the manufacturing of molecular biology
reagents at industrial scale.
More about the ARGENE® SARS-COV-2 R-GENE® diagnostic
test:
Like all the tests in the ARGENE® range, the SARS-COV-2 R-GENE®
test may be performed by any laboratory using PCR technology on
most commercially-available nucleic acid extraction and
amplification platforms. Results are delivered in 4 to 5 hours, and
a large number of patient samples may be processed
simultaneously.
The test relies on bioMérieux’s expertise and development
know-how and is designed to ensure a reliable diagnosis even if the
virus mutates. Therefore, it includes two tests: the first one
allows the specific detection of two genes of SARS-CoV-2, the
second detects the more pathogenic beta coronaviruses including,
SARS-CoV, SARS-like viruses, SARS-CoV-2, and MERS-CoV. It also
contains controls to measure the quality of the sample and the
testing process.
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/20200310006000/en/
Investor Relations bioMérieux Sylvain Morgeau
Tel.: + 33 4 78 87 51 36 investor.relations@biomerieux.com Media
Relations bioMérieux Aurore Sergeant Tel.: + 33 4 78 87
21 99 media@biomerieux.com Image Sept Laurence Heilbronn
Tel.: + 33 1 53 70 74 64 lheilbronn@image7.fr Claire Doligez Tel.:
+ 33 1 53 70 74 48 cdoligez@image7.fr
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