QIAGEN Tests Clinically Verified for the Monito...
German Bernhard Nocht Institute and Spanish Reference Laboratory
Unequivocally Detect Infections with the H1N1 Strain Using the artus
Influenza Test
Venlo, The Netherlands - April 30, 2009 - Analyses performed by the
German Bernhard Nocht Institute for Tropical Medicine have proven
that the influenza A / H1N1 virus can be unequivocally detected using
a screening test developed by QIAGEN (NASDAQ: QGEN; Frankfurt Prime
Standard: QIA). The company's artus Influenza LC RT PCR Kit was
successfully used to screen a female patient who had come down with
the disease in Mexico and is currently being treated at the Eppendorf
University Hospital in Hamburg, Germany. The patient is currently one
of three confirmed cases of swine flu in Germany. The results are a
clinical verification of the reliability of the QIAGEN test
demonstrated by the findings of a data analysis published the day
before.
QIAGEN's artus kit is considered to be one of the most widely used
assays in influenza screening and serves as standard for the
detection of influenza A viruses in numerous laboratories around the
world. The test was also used by the Instituto de Salud Carlos III,
Centro Nacional de MicrobiologÃa in Majadahonda (Spain), to screen
for Influenza A infections. Yesterday, the institute verified several
possible infections with the H1N1 strain that occurred during the
last few days. The national reference laboratory advises other
institutions in Spain seeking support that the artus influenza Kit
provides maximum reliability for the first-line screening for H1N1.
Following this recommendation, some Spanish hospitals yesterday began
to identify possible infections with H1N1 using the artus kit.
"QIAGEN's artus influenza test can be performed quickly and the
results are faultless. This demonstrates the artus test's ability to
detect infections with the influenza A virus including the currently
circulating Mexican H1N1 viruses," said Dr Stephan Guenther, Head of
Virology at the Bernhard Nocht Institute in Hamburg. Screening tests
enable quick and reliable verification of potential infections and
thus help to contain the spread of the epidemic. Patients that have
tested positive for influenza A can then be treated with one of the
commonly available pharmaceuticals such as Tamiflu or Relenza,
according to the recommendations given by the corresponding drug
manufacturers.
The infection with the H1N1 strain of influenza A in sample material
obtained from the patient treated in Hamburg was also successfully
detected using the company's second available screening test, the
ResPlex II v.2.0 Multiplex Assay. "The signals obtained during the
amplification of the corresponding viral sequence were unequivocal,
which shows that this test is reliable as well," said Dr Thomas
Grewing, Senior Director Research & Development at QIAGEN.
Regulatory approval of both products for in-vitro diagnostic
applications has not been sought yet by QIAGEN, but applications can
be officially submitted on a short-term basis depending on the
further proliferation of the disease.
Meanwhile, the U.S. FDA regulatory body has cleared tests developed
by the national Centers for Disease Control and Prevention (CDC) that
include QIAGEN test components. "The CDC tests use our consumables
for the extraction of genetic information from samples. One CDC test
also incorporates our enzymes needed for the amplification of viral
sequences to make the information visible," continued Grewing.
QIAGEN offers the broadest portfolio of molecular screening solutions
for viral infectious diseases. Public health institutions and more
than 80 reference laboratories around the globe use the company's
molecular tests and testing components for surveillance of and
research on viral infections. QIAGEN is the leading provider of Avian
Flu (H5N1) molecular detection tools and also developed the first
test for the detection of SARS.
About Swine Flu:
Swine flu (swine influenza) is a highly contagious respiratory
disease of pigs, caused by one of several swine influenza A viruses.
Since pigs can be infected with more than one virus type at a time,
genes of several viruses from various sources (including humans) can
mix, allowing the swine influenza viruses to cross the species
barrier and eventually cause disease in humans. The clinical symptoms
in humans are similar to seasonal influenza and other acute upper
respiratory tract infections, in some cases leading to severe
pneumonia and resulting in death. However, since mild or asymptomatic
cases may have gone unrecognized, the true extent of this disease
among humans is still unknown. Currently, there is no human vaccine
on the market which protects against swine influenza. Antiviral drugs
are available in many countries. More information on the swine flu is
available on www.who.int.
About QIAGEN:
QIAGEN N.V., a Netherlands holding company, is the
leading global provider of sample and assay technologies. Sample
technologies are used to isolate and process DNA, RNA and proteins
from biological samples such as blood or tissue. Assay technologies
are used to make such isolated biomolecules visible. QIAGEN has
developed and markets more than 500 sample and assay products as well
as automated solutions for such consumables. The company provides its
products to molecular diagnostics laboratories, academic researchers,
pharmaceutical and biotechnology companies, and applied
testing customers for purposes such as forensics, animal or food
testing and pharmaceutical process control. QIAGEN's assay
technologies include one of the broadest panels of molecular
diagnostic tests available worldwide. This panel includes the digene
HPV Test, which is regarded as the "gold standard" in testing for
high-risk types of human papillomavirus (HPV), the primary cause of
cervical cancer. QIAGEN employs more than 3,000 people in over 30
locations worldwide. Further information about QIAGEN can be found at
http://www.qiagen.com/.
Statements contained in this release that are not historical facts
are forward-looking statements, including statements about our
products, markets, strategy and operating results. Such statements
are based on current expectations that involve risks and
uncertainties including, but not limited to, those associated with:
management of growth and international operations (including currency
fluctuations and logistics), variability of our operating results,
commercial development of our markets (including applied testing,
clinical and academic research, proteomics, women's health/HPV
testing and molecular diagnostics), our relationships with customers,
suppliers and strategic partners, competition, changes in technology,
fluctuations in demand, regulatory requirements, identifying,
developing and producing integrated products differentiated from our
competitors' products, market acceptance of our products, and
integration of acquired technologies and businesses. For further
information, refer to our filings with the SEC, including our latest
Form 20-F. Information in this release is as of the date of the
release, and we undertake no duty to update this information unless
required by law.
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Contacts
Investor Media Relations
Relations Thomas Theuringer
Solveigh Maehler + 49 2103-29-11826
+ 49 2103-29-11710 E-mail:
thomas.theuringer@qiagen.com
For North America :
Al Fleury For North America:
+1 301 944 7028 Nicole York
+1-240-686-7660
E-mail: ir@qiagen.com Email: Nicole.York@qiagen.com
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