Regulatory News:
Today marks World Tuberculosis (TB) Day and bioMérieux
(Paris:BIM), a world leader in the field of in vitro diagnostics,
announces the CE marking of its innovative and fully-automated test
VIDAS® TB IGRA (Interferon-Gamma Release Assay) to diagnose latent
TB infection.
Tuberculosis continues to be a major global health problem. With
10 million new active cases and 1.4 million related deaths
worldwide in 20191, TB remains an important cause of mortality from
a single infectious disease.
It is estimated that a fourth of the global population is
infected with Mycobacterium tuberculosis, the bacteria responsible
for TB disease. In most cases (90-95%), people with healthy immune
systems can control the infection without developing the active
disease: this is called “Latent Tuberculosis Infection” (LTBI). The
remaining infected people (5-10%), will develop active TB disease
(aTB), making them sick as well as infectious to others.
“Despite all efforts, tuberculosis has not been eradicated and
remains a significant health problem for a large proportion of the
world’s population, especially in low- and middle-income countries.
Diagnosing people who have latent TB infection is an important tool
for global TB control. Detecting and then following or treating
people with latent TB infection can help in preventing their
progression to active disease, which would make them sick and also
infectious to others,” said Mark Miller, Executive Vice President
and Chief Medical Officer, bioMérieux.
There is no single gold standard for diagnosing LTBI. Current
diagnostic tools for LTBI include a detailed clinical history of
exposure to TB, the tuberculin skin test (TST) or an IGRA test,
which are indirect diagnostic methods based on the host immune
response to the pathogen2.
Despite their improved performances over TST, current IGRA tests
are cumbersome, consist of many manual steps, and can negatively
impact the lab workflow. There is a need for improved TB-IGRA tests
having complete automation, standardization of each step, faster
time to results, more accurate and reliable clinical performances
and increased ease-of-use for any lab without specialized
expertise.
VIDAS® TB-IGRA is the new fully automated assay intended as
an aid in the diagnosis of infection with Mycobacterium
tuberculosis.
Performed on the VIDAS® 3 platform, VIDAS® TB-IGRA provides
reliable test results and improves current workflow compared to
existing TB-IGRA solutions.
The complete test process is fully automated from sample to
result interpretation, including the stimulation step. Only one
whole blood sample tube is needed with no manual sample
preparation. Thanks to this simplified “load & start” process,
laboratories will now be able to easily manage TB-IGRA testing
in-house and deliver faster results to clinicians without
additional cost.
In addition to full automation, VIDAS® TB-IGRA demonstrated
strong clinical performances3. Clinical trials conducted on
populations coming from different areas around the world
demonstrated a better sensitivity in an active TB population
compared to an existing test (97% vs 80,6%*), a high specificity of
97.5% in populations at very low risk of being TB infected ** and a
strong agreement with the comparative assay* on populations at
mixed risk levels of TB infection. Furthermore, significantly fewer
indeterminate results (0,1% vs 1,3%*) were observed.
“For more than 55 years, bioMérieux has been driven by a
pioneering spirit and unrelenting commitment to improve public
health worldwide. It is a great achievement for us to provide
laboratories with a fully automated assay with high performances to
detect latent tuberculosis. As we commemorate World Tuberculosis
Day today, the launch of VIDAS® TB-IGRA reaffirms our commitment to
help end tuberculosis by detecting infected individuals,” declared
Alexandre Mérieux, Chief Executive Officer, bioMérieux.
VIDAS® TB-IGRA will be gradually deployed in countries that
recognize CE marking. Hospitals and private laboratories will be
able to run the test on bioMérieux’s VIDAS® 3 system, which allows
for higher automation and traceability. bioMérieux is planning a
submission for FDA clearance in the near future.
*Comparative assay used during clinical trials is a CE-marked
and FDA-cleared TB-IGRA test
** Specificity assessed in healthy blood donors from a country
with low TB prevalence
ABOUT VIDAS®
Launched 30 years ago, VIDAS® has transformed the field of
immunoassays offering laboratories universal access to a simple,
automated and robust technology providing fast and reliable
results. Today, VIDAS® is still the most widely used immunoassay
system in clinical laboratories worldwide.
The VIDAS® menu covers a wide range of pathologies, including
infectious diseases and a range of tests dedicated to emergency and
critical care. A number of these parameters are part of the
bioMérieux full solution to address the global challenges of
antimicrobial resistance (AMR) and sepsis. As it enters into its
fourth decade, VIDAS® remains a major focus of the bioMérieux
immunoassay strategy with ongoing research into new parameters and
frequent launches that create value for labs and clinicians, for
the benefits of the patients.
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 2020, revenues reached €3.1 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.
REFERENCES
1. World Health Organization. Tuberculosis [fact sheet].
Published on October 14, 2020.
https://www.who.int/news-room/fact-sheets/detail/tuberculosis.
2. World Health Organization. Latent tuberculosis infection
(LTBI) - FAQs. Published in 2015.
https://www.who.int/tb/areas-of-work/preventive-care/ltbi/faqs/en/
3. VIDAS® TB-IGRA Package insert 053331
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version on businesswire.com: https://www.businesswire.com/news/home/20210323006000/en/
Investor Relations bioMérieux Franck Admant Tel.:
+ 33 4 78 87 20 00 investor.relations@biomerieux.com
Media Relations bioMérieux Romain Duchez Tel.: +
33 4 78 87 20 00 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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