Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro
diagnostics, has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) for the expanded use of
VIDAS® B•R•A•H•M•S PCT™, an automated assay measuring
procalcitonin (PCT) levels, to help clinicians make important
decisions regarding the optimal use of antibiotics in two common
clinical situations: lower respiratory tract infections (LRTI) and
sepsis.
With these two new additional claims,
VIDAS® B•R•A•H•M•S PCT™ becomes the first and only
FDA-cleared procalcitonin test available in the U.S. market to
assist physicians in antibiotic management for patients with
suspected or confirmed LRTI or sepsis. In the case of patients with
LRTI, VIDAS® B•R•A•H•M•S PCT™ will aid physicians in
decision-making to safely reduce overall antibiotic use. In the
case of sepsis patients, VIDAS® B•R•A•H•M•S PCT™ will aid
physicians on deciding when antibiotics can be safely discontinued.
Using VIDAS® B•R•A•H•M•S PCT™ in these frequent and
important clinical situations will help reduce inappropriate and
unnecessary antibiotic use, which may avoid the side effects
associated with their use while slowing and preventing the
emergence of resistant bacteria.
“Committed to the diagnosis of infectious diseases for more than
50 years, we are very honored to receive this innovative claim
expansion. Antimicrobial resistance is considered as a major threat
to public health and this FDA clearance illustrates our capacity to
provide clinicians with high medical value tests to help them make
important treatment decisions. The goal is to achieve better
outcomes for patients and to ensure that each of them receives the
appropriate treatment,” said Mark Miller, Corporate VP, Chief
Medical Officer at bioMérieux.
“True to its pioneering spirit, bioMérieux worked with the FDA
to develop a strategy which undertook a comprehensive evaluation of
the published literature and conducted an in-depth analysis –
termed a meta-analysis – to support the two new indications
for use. These studies validated the vital role of
VIDAS® B•R•A•H•M•S PCT™ as an aid for antibiotic
stewardship and the important role which diagnostic tests can play
to curb the rise of multi-resistant bacteria,” highlighted Sam
Bozzette, Medical Affairs Americas at bioMérieux.
Originally FDA-cleared in 2007,
VIDAS® B•R•A•H•M•S PCT™ was the first automated test
measuring procalcitonin in the U.S. to aid in the risk assessment
for sepsis and septic shock on the first day following admission to
an intensive care unit (ICU). In June 2016, this test received an
additional FDA clearance to aid in assessing the risk of mortality
for patients with severe sepsis by monitoring PCT levels serially
over 96 hours.
About VIDAS®
The VIDAS® automated immunoassay platform, designed for small
test series, is well-suited to emergency situations. The very broad
menu of tests allows clinicians to provide diagnosis, monitoring
and prognosis for a number of diseases, particularly in the field
of infectious diseases and emergency testing. Among them,
VIDAS® B•R•A•H•M•S PCT™ provides test results in just 20
minutes. With over 30,000 instruments used by clinical laboratory
professionals, the VIDAS® range has the largest installed base of
automated laboratory immunoassay systems in the world1, which
makes this innovation available to a large number of hospitals.
About Lower Respiratory Tract Infections
Lower respiratory tract infections (LRTI), are common across all
age groups. In 2013, there were about 150 million reported LRTIs2.
These resulted in 2.7 million deaths, accounting for 4.8% of all
deaths in 20133. LRTI represents a leading cause of clinic visits
and admissions to the hospital following an Emergency Department
visit4, and collectively includes the syndromes of
community-acquired pneumonia (CAP), acute bronchitis, and acute
exacerbations of chronic obstructive pulmonary Disease (AECOPD).
These three conditions are commonly treated with antibiotics
despite the fact that a large proportion are caused by reasons
which do not require the administration of antibiotics5.
About Sepsis
Sepsis is a severe infection in which the human immune response
leads to life-threatening organ dysfunction. Around 27 million
people in the world are affected by sepsis each year. In its most
severe form, septic shock, there is a 30% mortality. Making the
diagnosis as fast as possible, defining and administering the most
appropriate antibiotic therapy and knowing when to safely stop
antibiotic treatment represent the current major unmet medical
needs in this medical condition which could lead to less
antimicrobial resistance while safely improving patient
outcomes.
bioMérieux’s pledge to fight sepsis
VIDAS® B•R•A•H•M•S PCT™ is part of bioMérieux’s sepsis
solution range. bioMérieux’ offering enables workflow optimization,
allowing the sepsis patients’ samples to reach the laboratory and
be analyzed rapidly. It also comprises: blood cultures with
BacT/ALERT® or BacT/ALERT® VIRTUO™, a new fully automated CE-marked
blood culture system making 24/7 reception and processing of these
urgent samples possible; the molecular syndromic FilmArray® BCID
Panel, which in 1 hour, and with only 2 minutes hands-on time,
allows pathogen identification; VITEK® MS for automated fast
identification of pathogens using MALDI-TOF spectrometry; and
VITEK® 2 for automated reliable pathogen identification and
antibiotic susceptibility testing.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for over 50
years, bioMérieux is present in more than 150 countries
through 42 subsidiaries and a large network of distributors. In
2016, revenues reached €2,103 million, with more than 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 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/Reuters: BIOX.PA/Bloomberg: BIM.FP – ISIN:
FR0010096479).
Corporate website: www.biomerieux.com Investor website:
www.biomerieux-finance.com
1 CAP Today, July 2016
2 Global Burden of Disease Study 2013, Collaborators (22 August
2015). "Global, regional, and national incidence, prevalence, and
years lived with disability for 301 acute and chronic diseases and
injuries in 188 countries, 1990-2013: a systematic analysis for the
Global Burden of Disease Study 2013.". Lancet (London,
England)
3 GBD 2013 Mortality and Causes of Death, Collaborators (17
December 2014). "Global, regional, and national age-sex
specific all-cause and cause-specific mortality for 240 causes of
death, 1990-2013: a systematic analysis for the Global Burden of
Disease Study 2013.". Lancet.
4
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb174-Emergency-Department-Visits-Overview.pdf
5 Shapiro D J, Hicks L A, Pavia A T, Hersh A L. Antibiotic
prescribing for adults in ambulatory care in the USA, 2007–09.
Journal of Antimicrobial Chemotherapy 2013
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Investor RelationsbioMérieuxSylvain MorgeauTel.:
+33 (0)4 78 87 22 37investor.relations@biomerieux.comorMedia
RelationsbioMérieuxAurore SergeantTel.: +33 (0)4 78 87
54 75media@biomerieux.comorTim BakerTel.: +1
216-407-5354timothy.baker@biomerieux.comorImage SeptLaurence
HeilbronnTel.: +33 (0)1 53 70 74 64lheilbronn@image7.frorClaire
DoligezTel.: +33 (0)1 53 70 74 48cdoligez@image7.fr
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