Regulatory News:
Eurofins (Paris:ERF):
As one of the first commercial
labs to deliver COVID-19 testing, Eurofins Viracor, Inc. continues
to invest in innovation with the launch of Coronavirus SARS-CoV-2
inSIGHT™ T Cell Immunity testing. Viracor’s inSIGHT™ T Cell
Immunity test delivers a deeper understanding of a patient's
response to viral antigens and gives healthcare providers critical
insight to aid in treatment decisions. The test measures CD4+ and
CD8+ T Cells independently to evaluate cell- mediated immunity to
Coronavirus SARS-CoV-2 that causes COVID-19.
Utilizing flow cytometry and
intracellular cytokine staining, SARS-CoV-2 inSIGHT™ testing could
be an important tool for evaluating an individual’s immunological
memory to the SARS-CoV-2 virus and even indicate a level of
protection from further infection with the virus. The ability to
determine the proportion of antigen specific T cells that respond
to stimulation with SARS-CoV-2 spike (S) and nucleocapsid (N)
proteins can assist even the most critical and immunocompromised
patients, such as transplant recipients, those battling cancer and
more. Results for this live cell test, collected in a sodium
heparin test tube, can be available in 3 to 4 business days from
receipt of specimen.
SARS-CoV-2 inSIGHT™ testing
joins a robust menu of COVID-19 testing, including the
recently-launched cPASS™ Coronavirus SARS-CoV-2 Neutralizing
Antibody test. If SARS-CoV-2 inSIGHT™ is used in combination with
the cPass™ Coronavirus SARS-CoV-2 Neutralizing Antibody test, the
results from the two tests could help physicians evaluate two areas
of our adaptive immune system that can give indication of immunity.
When neutralizing antibody response begins to diminish months after
exposure to the virus or vaccine, the presence of T cell immunity
may signify long-term immunity.
A leader in infectious disease
testing for over 35 years, Viracor has launched molecular and
serological tests to aid in the evaluation of naturally infected or
vaccinated individuals. Available testing includes RT-PCR, IgG, IgM
and Neutralizing Antibody testing to help identify individuals with
active or prior COVID-19 cases. Furthermore, Viracor's SARS-CoV-2
RT-PCR assay offers the best sensitivity of the 117 laboratories
that have submitted results to FDA's SARS-CoV-2 Reference Panel,
with a limit of detection of 180 NAAT Detectable
Units/mL1,2. To see the
full list of available testing, visit
https://www.eurofins-viracor.com/clinical/our-testing/.
1 This test has not been cleared or approved
for diagnostic use by the U.S. Food and Drug Administration. This
test has been authorized by FDA under an EUA for use by authorized
laboratories. This test has been authorized only for the detection
of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus
infection, not for any other viruses or pathogens. This test is
only authorized for the duration of the declaration that
circumstances exist justifying the authorization of the emergency
use of in vitro diagnostic tests for detection of SARS-CoV-2 virus
and/or diagnosis of SARS-CoV-2 virus infection under section
564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
2 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data
Notes to Editors:
For more information, please visit www.eurofins.com
About Viracor
With over 30 years of specialised expertise in infectious
disease, immunology and allergy testing for immunocompromised and
critical patients, Viracor Eurofins is committed to delivering
results to medical professionals, transplant teams, reference
laboratories and biopharmaceutical companies faster, when it
matters most. Eurofins Viracor is passionate about delivering value
to its clients by providing timely, actionable information, never
losing sight of the connection between the testing it performs and
the patients it ultimately serves.
Eurofins Viracor is a subsidiary of Eurofins Scientific
(EUFI.PA), a global leader in bio-analytical testing, and one of
the world leaders in genomic services. For more information, please
visit https://www.eurofins.com/ and
https://www.eurofins-viracor.com/.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. Eurofins is the global leader in
food, environment, pharmaceutical and cosmetic product testing and
in agroscience Contract Research Organisation services. Eurofins is
one of the market leaders in certain testing and laboratory
services for genomics, discovery pharmacology, forensics, advanced
material sciences and in the support of clinical studies, as well
as having an emerging global presence in Contract Development and
Manufacturing Organisations. The Group also has a rapidly
developing presence in highly specialised and molecular clinical
diagnostic testing and in-vitro diagnostic products.
With over 50,000 staff across a decentralised and
entrepreneurial network of more than 800 laboratories in over 50
countries, Eurofins offers a portfolio of over 200,000 analytical
methods to evaluate the safety, identity, composition,
authenticity, origin, traceability and purity of a wide range of
products, as well as providing innovative clinical diagnostic
testing services and in-vitro diagnostic products.
The Group’s objective is to provide its customers with
high-quality services, innovative solutions and accurate results on
time. Eurofins is ideally positioned to support its clients’
increasingly stringent quality and safety standards and the
increasing demands of regulatory authorities as well as the
requirements of healthcare practitioners around the world.
In 2020, Eurofins reacted quickly to meet the global challenge
of COVID-19, by creating the capacity to help over 20 million
patients monthly who may have been impacted by the pandemic with
our testing products and our services and directly supporting
healthcare professionals working on the front line to fight the
virus. The Group has established widespread PCR testing
capabilities and has carried out over 25 million tests in its own
laboratories, is supporting the development of a number of vaccines
and has established its SAFER@WORK™ testing, monitoring and
consulting programmes to help ensure safer environments during
COVID-19.
Eurofins has grown very strongly since its inception and its
strategy is to continue expanding its technology portfolio and its
geographic reach. Through R&D and acquisitions, the Group draws
on the latest developments in the field of biotechnology and
analytical chemistry to offer its clients unique analytical
solutions.
Shares in Eurofins Scientific are listed on the Euronext Paris
Stock Exchange (ISIN FR0014000MR3, Reuters EUFI.PA, Bloomberg ERF
FP).
Until it has been lawfully made public widely by Eurofins
through approved distribution channels, this document contains
inside information for the purpose of Regulation (EU) 596/2014 of
the European Parliament and of the Council of 16 April 2014 on
market abuse, as amended.
Important disclaimer:
This press release contains forward-looking statements and
estimates that involve risks and uncertainties. The forward-looking
statements and estimates contained herein represent the judgment of
Eurofins Scientific’s management as of the date of this release.
These forward-looking statements are not guarantees for future
performance, and the forward-looking events discussed in this
release may not occur. Eurofins Scientific disclaims any intent or
obligation to update any of these forward-looking statements and
estimates. All statements and estimates are made based on the
information available to the Company’s management as of the date of
publication, but no guarantees can be made as to their completeness
or validity.
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Investor Relations Eurofins Scientific SE Phone: +32 2 766 1620
E-mail: ir@eurofins.com
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