BioFire’s FilmArray® Meningitis/Encephalitis Panel Gets CE Marked
26 Janvier 2016 - 7:00AM
Business Wire
FilmArray® expanded menu, with a fourth panel,
is the largest available on a molecular biology multiplex
platform
Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of
in vitro diagnostics, today announced the availability of
BioFire Diagnostics’ FilmArray® Meningitis/Encephalitis (ME)
Panel in the countries which recognize CE marking. The ME
Panel provides unique and highly beneficial medical value, as it
addresses the critical unmet need for quick and accurate
identification of central nervous system (CNS) infectious agents.
The comprehensive ME Panel tests cerebrospinal fluid (CSF) for the
14 most common pathogens (6 bacteria, 7 viruses and 1 yeast)
responsible for community acquired meningitis or encephalitis in
about an hour. Currently, testing CSF for multiple organisms can
take days and is not always possible because it can be difficult to
obtain enough fluid from each patient to run multiple tests.
The ME Panel received a de novo clearance by the U.S. Food
and Drug Administration (FDA) in October 2015.
“In Europe, the ME Panel brings a unique opportunity to test
simultaneously and rapidly for most bacteria, viruses and fungi
found in those pathologies that can be extremely severe and
sometimes lethal,” states François Simon, MD, Head, Department of
Virology, Bacteriology and Hygiene at Hospital Saint-Louis -
Lariboisière - Fernand Widal, Paris, France. “Such an approach will
positively impact the management of those patients by helping
clinicians and biologists speed the diagnosis of these potentially
severe conditions and make much faster decisions on appropriate
therapy to prevent complications.”
Randy Rasmussen, bioMérieux Corporate Vice President of
Molecular Biology and CEO of BioFire Diagnostics, adds: “The
FilmArray® ME Panel revolutionizes infectious disease testing for
CNS infections and patient care. Time is critical for treating
these severe diseases and within about an hour FilmArray® provides
physicians the complex diagnostic information they need to properly
manage their patients.” Rasmussen continues, “the FilmArray®
ME Panel further solidifies our leadership in syndromic infectious
disease testing with now four IVD panels launched in four
years.”
More than 1.2 million people every year are affected by
meningitis worldwide, resulting in 120,000 deaths globally from
bacterial meningitis. Bacterial meningitis can occur suddenly in
healthy people and even with prompt diagnosis and treatment,
approximately 10% of patients may die and up to 20% or more may
sustain permanent damage and disability1.
The ME Panel is cleared for the FilmArray® and FilmArray® 2.0
systems and is commercially available around the globe.
About FilmArray®
FilmArray® is a FDA-cleared and CE-marked multiplex PCR
molecular biology system that is easy to use, accurate and rapid.
FilmArray® has the largest infectious disease pathogen menu
commercially available: it currently comprises four panels – upper
respiratory, blood culture identification, gastrointestinal and
meningitis/encephalitis – all of which are FDA-cleared and
CE-marked.
At the end of 2015, the total number of FilmArray® systems
installed at customer sites was about 2,500 instruments and sales
grew 80% year-on-year demonstrating the rapid adoption of
FilmArray® by clinical laboratories.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for 50
years, bioMérieux is present in more than 150 countries through 42
subsidiaries and a large network of distributors. In 2015, revenues
reached €1,965 million with 90% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments,
software) which determine the source of disease and contamination
to improve patient health and ensure consumer safety. Its products
are used for diagnosing infectious diseases and providing high
medical value results for cancer screening and monitoring and
cardiovascular emergencies. 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: FR0010096479).
Corporate website: www.biomerieux.com - Investors website:
www.biomerieux-finance.com
More information on FilmArray® : www.biofiredx.com
1 http://www.comomeningitis.org/facts-about-meningitis/ ;
accessed January 22, 2016
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Investor RelationsbioMérieuxSylvain Morgeau, + 33
(0)4 78 87 22
37investor.relations@biomerieux.comorMediaRelationsbioMérieuxAurore
Sergeant, + 33 4 78 87 54 75media@biomerieux.comorBioFire
Diagnostics, LLCMari Hoidal, 801-736-6354
x774Mari.Hoidal@biofiredx.comorImage SeptLaurence Heilbronn,
33 1 53 70 74 64lheilbronn@image7.frorClaire Doligez, + 33 1 53 70
74 48cdoligez@image7.fr
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