BIOMERIEUX (EPA:BIM) - bioMérieux announces the CE marking of the new generation semi-quantitative VIDAS® SARS-COV-2 IgG II serology test

Transparency directive : regulatory news

10/05/2021 07:01

bioMérieux announces the CE marking of the new generation semi-quantitative
                    VIDAS(r) SARS-COV-2 IgG II serology test.

Marcy l'Étoile, France - May 10, 2021 - bioMérieux, a world leader in the
field of in vitro diagnostics, today announces CE marking of the new generation
of IgG serology test with VIDAS(r) SARS-COV-2 IgG II to semi-quantitatively
detect antibodies in people who have been exposed to the SARS-CoV-2 that causes
the COVID-19 disease.

In 2021, on top of the importance of detecting COVID-19 virus, the emergence of
variant strains and expansion of vaccination have generated new public health
challenges. In particular, obtaining quantitative serological information by
measuring antibody levels might provide important insights to help evaluate a
person's immune response following either natural infection or vaccination.

VIDAS(r) SARS-COV-2 IgG II offers a semi-quantitative interpretation of the
level of IgG antibodies directed against the Receptor-Binding Domain (RBD) of
the Spike (S) viral protein. Indeed numerous vaccines for COVID-19 are
available, mostly focusing on eliciting an immune response to the RBD / S viral
protein. Following an internal evaluation with two of the more common vaccines
(Pfizer-BioNTech Comirnaty and Moderna mRNA-1273), it was demonstrated that
this new VIDAS(r) assay will detect anti- SARS-Cov-2 IgG antibodies
post-vaccination. Additionally, we have documented correlation of the IgG level
results with the WHO international standard.

"Building on three decades of experience in immunoassays, the VIDAS(r)
SARS-COV-2 IgG II will support labs with a solution adapted to new medical
needs linked to the evolution of the COVID-19 pandemic." declared François
Lacoste, Executive Vice President, R&D, bioMérieux.

Hospitals and private laboratories can run this new test on bioMérieux's
VIDAS(r) analyzers (MINI VIDAS(r), VIDAS(r) and VIDAS(r) 3) which are widely
available with more than 30,000 systems installed around the world.

"bioMérieux is committed to fight against the spread of COVID-19 with both
molecular biology and immunoassay solutions. Our large VIDAS(r) installed base
and easy-to-use platform will provide a wide access to this new antibody test."
said Pierre Boulud, Chief Operating Officer, Clinical Operations,
bioMérieux.

ABOUT BIOMÉRIEUX'S GLOBAL RESPONSE TO COVID-19

bioMérieux provides several SARS-CoV-2 diagnostic solutions(*):

1. Molecular biology :

- BIOFIRE(r) Respiratory Panel 2.1 (RP2.1): this panel includes SARS-CoV-2 in
  addition to 21 other common respiratory pathogens and delivers results in
  approximately 45 minutes. BIOFIRE(r) Respiratory Panel 2.1 plus, available in
  international markets, includes the 21 common respiratory pathogens plus
  detection of MERS-Coronavirus in addition to the SARS-CoV-2 virus.
- BIOFIRE(r) Respiratory 2.1-EZ Panel: this panel identifies 19 pathogens
  associated with respiratory infections, including SARS-CoV-2 in approximately
  45 minutes, and is used in point of care and near patient (e.g. CLIA-waived)
  settings. Available in the US only.
- ARGENE(r) SARS-COV-2 R-GENE(r) and SARS-COV-2 RESPI R-GENE(r): these tests
  are available in certain international markets outside of the US and rely on
  real-time PCR technology and can be used with most commercially available
  amplification PCR-platforms. The SARS-COV-2 RESPI R-GENE(r) allows the
  simultaneous (multiplex) detection of SARS- COV-2, influenza viruses A and B
  and two other respiratory pathogens (RSV and hMPV).
- EMAG(r) and easyMAG(r): equipment and associated reagents are pivotal for the
  extraction of nucleic acids prior to the amplification and detection of
  specific gene sequences. These systems are in high demand as a means of
  preparing nucleic acids from clinical specimens.

2. Immunoassays :

- VIDAS(r) SARS-COV-2 IgM and SARS-COV-2 IgG: these two qualitative serology
  tests detect antibodies as an aid in identifying individuals with an adaptive
  immune response to SARS-CoV-2, indicating recent or prior infection
- VIDAS(r) SARS-COV-2 IgG II: this semi-quantitative serology test detects
  antibodies as an aid in identifying individuals with an adaptive immune
  response to SARS-CoV-2, indicating prior infection or vaccination with
  certain vaccines and the level of anti-SARS-CoV2 IgG antibodies.

(*) Some references may vary according to the country and regulatory clearance
in some countries may not have been obtained yet.

ABOUT VIDAS(r)

Launched 30 years ago, VIDAS(r) has transformed the field of immunoassays
offering laboratories universal access to a simple, automated and robust
technology providing fast and reliable results. Today, VIDAS(r) is still the
most widely used immunoassay system in clinical laboratories worldwide.

The VIDAS(r) menu covers a wide range of pathologies, including infectious and
chronic 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(r) 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
EUR3.1 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.

CONTACTS

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

source : webdisclosure.com

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BIOMERIEUX (EPA:BIM) - bioMérieux announces the CE marking of the new generation semi-quantitative VIDAS® SARS-COV-2 IgG II serology test

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