Test Provides U.S. Physicians and Patients
Same Day Results and the Option to Test Urine Alongside
Blood
Regulatory News:
Viracor-IBT Laboratories Inc. (Viracor-IBT), a wholly-owned
subsidiary of Eurofins Scientific (Paris:ERF) (EUFI.PA), today
announced that it received Emergency Use Authorization (EUA) from
the U.S. Food and Drug Administration (FDA) for its Zika Virus
Real-time RT-PCR assay. Viracor-IBT will perform this assay under
CLIA/CAP regulations for High Complexity Clinical Laboratories. The
assay has been approved by the New York State Department of Health
(NYSDOH). The proprietary molecular Zika virus test is a real-time
RT-PCR assay intended for the qualitative detection of RNA from
Zika virus in human serum, plasma, or urine (collected alongside a
patient-matched serum or plasma specimen) collected from
individuals meeting Zika virus clinical criteria (e.g., clinical
signs and symptoms associated with Zika virus infection) and/or
Zika virus epidemiological criteria (e.g., history of residence in
or travel to a geographic region with active Zika transmission at
the time of travel, or other epidemiologic criteria for which Zika
virus testing may be indicated).
Viracor-IBT’s Zika Virus Real-time RT-PCR has excellent
sensitivity and does not cross-react with other viruses in the
Flaviviridae family (including dengue virus, Japanese encephalitis
virus, West Nile virus and St. Louis encephalitis virus) or with
other viruses known to cause similar clinical symptoms such as
chikungunya virus. According to the Centers for Disease Control and
Prevention (CDC), during the first week after onset of symptoms,
Zika virus disease can often be diagnosed by performing real-time
reverse transcription-polymerase chain reaction (RT-PCR) on serum.
Additionally, urine samples collected less than 14 days after onset
of symptoms are recommended for RT-PCR testing, when collected
alongside a patient-matched serum or plasma specimen.
Dr. Gilles Martin, Eurofins’ CEO said, “As a leader and trusted
laboratory partner specialized in and dedicated to improving
patient care through innovative infectious disease testing,
Viracor-IBT is thrilled to be one of the first commercial
laboratories to offer the Zika RT-PCR test to hospitals and health
systems, and we are pleased that the FDA recently authorized our
assay. Viracor-IBT’s Zika test provides timely, accurate results
and more testing options to doctors and patients.”
Zika virus is primarily spread through mosquitos and can also be
spread by some forms of sexual contact. Zika virus has been linked
to microcephaly in newborns and is at the forefront of concern for
emerging infectious diseases. The Zika virus outbreak in South
America has potential to further reach North America with the onset
of the mosquito season, and Viracor-IBT will be prepared to assist
patients by providing a fast turnaround time (within 8-12 hours of
specimen receipt) on test results.
“Viracor-IBT has a proven history of developing and validating
highly sensitive, accurate assays in response to emerging public
health needs, like Zika virus. In 2009, Viracor-IBT was one of the
first laboratories to market with the H1N1 Influenza A RT-PCR
assay. We are committed to developing high quality infectious
disease assays that help our clients help more patients,” said
Steve Kleiboeker, PhD, HCLD/TS/CC (ABB), Vice President of Research
and Development, Viracor-IBT.
Viracor-IBT’s PCR assay development goes above and beyond
“traditional” real-time PCR and RT-PCR design in that redundancy is
present in the assay to account for the full range of viral
serotypes, genotypes or isolates that may be infecting patients.
With this expert approach to assay design, a problematic viral
genomic polymorphism on one target will not result in inaccurate
quantification or false positive results. Like all other EUA
authorizations, the Zika Virus Real-time RT-PCR test has not been
FDA cleared or approved and is only authorized for use for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostic tests for
detection of Zika virus and/or diagnosis of Zika virus
infection.
For more information please visit
http://www.eurofins.com
Notes for the editor:Eurofins – a global leader in
bio-analysis
Eurofins Scientific believes it is the world leader in food,
environment and pharmaceutical products testing, as well as one of
the global market leaders in agroscience, genomics, discovery
pharmacology and central laboratory services. In addition, Eurofins
is one of the key emerging players in specialty clinical diagnostic
testing in Europe and the USA.
With over 23,000 staff in more than 225 laboratories across 39
countries, Eurofins offers a portfolio of over 130,000 validated
analytical methods for evaluating the safety, identity,
composition, authenticity, origin, traceability and purity of
biological substances and products, as well as for innovative
clinical diagnostic. The Group provides its customers with
high-quality services, accurate results on time and expert advice
by its highly qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by
expanding both 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 and the most
comprehensive range of testing methods.
As one of the most innovative and quality oriented international
players in its industry, Eurofins is ideally positioned to support
its clients’ increasingly stringent quality and safety standards
and the expanding demands of regulatory authorities and healthcare
practitioners around the world.
The shares of Eurofins Scientific are listed on the Euronext
Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg
ERF FP).
About Viracor-IBT Laboratories
With over 30 years of specialized expertise in infectious
disease, immunology and allergy testing for immunocompromised and
critical patients, Viracor-IBT is committed to helping medical
professionals, transplant teams, reference laboratories and
biopharmaceutical companies get results faster, when it matters
most. Viracor-IBT 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. Viracor-IBT is a 100 percent
subsidiary of Eurofins Scientific (EUFI.PA), the global leader in
bio-analytical testing, and one of the world leaders in genomic
services. For more information, please visit www.eurofins.com and
www.viracoribt.com
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 judgement of Eurofins Scientific’
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 guarantee can be made as to their validity.
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version on businesswire.com: http://www.businesswire.com/news/home/20160720005705/en/
Investor RelationsEurofins ScientificPhone: +32 2 766
1620E-mail: ir@eurofins.comorViracor-IBTCorporate
CommunicationsJenni Miller, Phone: +1 800 305 5198E-mail:
jenni.miller@viracoribt.com
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