QIAGEN Launches First QIAplex Products for Highly Multiplexed,
PCR-Based Assays
Venlo, The Netherlands, June 1, 2007 - QIAGEN (Nasdaq: QGEN,
Frankfurt, Prime Standard: QIA), the world's leading provider of
sample and assay technologies for research in life sciences, applied
testing, and molecular diagnostics, today announced the launch of the
first assays based on its breakthrough QIAplex PCR multiplex
technology. QIAplex PCR allows highly sensitive detection of multiple
molecular targets in one test.
Samples that could contain multiple pathogens such as viruses and
bacteria as well as other disease markers, previously had to be
analyzed with assays that typically test for only one molecular
target. Such tests are costly, take time and in the case of negative
results lead to sequential testing for one potential target after the
other. QIAplex-based multiplexing has significant advantages compared
with single-target assays, since one to up to 20 targets can be
detected in only one test using the same sample. This permits
sensitive and simultaneous analyses of multiple nucleic acid
targets.
The newly developed and launched QIAplex panels, ResPlex(TM) I Panel,
ResPlex(TM) II Panel and StaphPlex(TM) Panel, allow parallel
detection of more than ten bacterial and viral targets in a single
reaction. The panels are launched in QIAGEN format as research use
only products.
"The striking advantages of the QIAplex panels are the simultaneous
detection of a group of targets as well as early and highly sensitive
recognition of multiple targets", said Dr. Jens Dannenberg, global
product manager at QIAGEN. "QIAGEN's multiplex PCR technologies open
completely new possibilities to the customer and are a perfect
addition to QIAGEN's product portfolio of preanalytical products and
real-time PCR assays."
ResPlex I and ResPlex II Panels detect respiratory bacterial and
viral nucleic acids for research applications. The ResPlex I Panel
enables the detection of most relevant respiratory bacterial DNA.
This includes DNA specific for Legionella pneumophila, Chlamydia
pneumoniae, or Mycoplasma pneumoniae, bacteria that cause atypical
pneumonia. Furthermore, the ResPlex I Panel detects DNA specific for
S. pneumoniae, H. influenzae and N. meningitidis. The ResPlex II
Panel was developed for the detection of respiratory viral RNA from
influenza and parainfluenza viruses, RSV, metapneumovirus, and
rhinoviruses.
The StaphPlex Panel allows identification of MRSA
(methicillin-resistant Staphylococcus aureus) DNA for research
applications. MRSA represents the most common nosocomial infection
and describes bacterial strains resistant to antibiotics. In some
hospitals up to 30% of hospital-acquired infections are due to MRSA.
The StaphPlex Panel also differentiates between two forms, the
community-acquired CA-MRSA and hospital-acquired HA-MRSA.
All QIAplex panels share a proprietary, PCR-based multiplex
amplification technology that permits high analytical sensitivity and
specificity. This is of particular importance in the area of
infectious disease research. The technology can be used in
combination with various, widely used detection platforms such as
arrays, capillary electrophoresis and bead-based detection systems.
The now launched QIAplex products have been designed for use on
Luminex® detection platforms and are optimized for use with QIAGEN's
LiquiChip® 200 Workstation.
QIAGEN is today recognized as a leading company in the area of
molecular diagnostics. In late 2006, QIAGEN also acquired Genaco
Biomedical Products, an early-stage company applying its proprietary
PCR-based multiplexing technology to develop molecular differential
detection. QIAGEN is in the process of compiling a FDA pre-market
submission for certain QIAplex products, including one panel intended
to confirm the presence and type of H5N1 avian influenza A strain in
respiratory specimens.
The technology used in QIAplex:
The multiplex molecular differential detection is mediated by a
proprietary amplification technology based on polymerase chain
reaction (PCR) involving two pairs of specific primers per target.
This allows an initial enrichment of target-specific nucleic acids.
SuperPrimers are used to facilitate efficient amplification of all
targets. Relative concentrations of all primers within a QIAplex
panel optimize the amplification of target nucleic acids.
The readout following the QIAplex assay can be performed on the
LiquiChip 200 Workstation through hybridization to suspension arrays
(xMAP® technology, Luminex). Specifically developed QIAplex MDD
Software enables convenient research data evaluation.
Über QIAGEN:
QIAGEN N.V., a Netherlands holding company is the leading provider of
innovative sample and assay technologies and products. QIAGEN's
products are considered standards in areas such pre-analytical sample
preparation and assay solutions in research for life sciences,
applied testing and molecular diagnostics. QIAGEN has developed a
comprehensive portfolio of more than 500 proprietary, consumable
products and automated solutions for sample collection, nucleic acid
and protein handling, separation, and purification and open and
target specific assays. The company's products are sold to academic
research markets, to leading pharmaceutical and biotechnology
companies, to applied testing customers (such as in forensics,
veterinary, biodefense and industrial applications) as well as to
molecular diagnostics laboratories. QIAGEN employs more than 1,900
people worldwide. QIAGEN products are sold through a dedicated sales
force and a global network of distributors in more than 40 countries.
In this press release QIAGEN is using the term molecular diagnostics.
The use of this term is in reference to certain countries, such as
the United States, limited to products subject to regulatory
requirements. Current QIAGEN molecular diagnostics products are 34 EU
CE IVD assays, six EU CE IVD sample preparation products, one 510k
PAX RNA product, nine China SFDA IVD assays and 98 general purpose
reagents. Further information about QIAGEN can be found at
www.qiagen.com.
About QIAGEN Hamburg:
QIAGEN Hamburg GmbH specializes in the development and marketing of
diagnostic tests based on modern, DNA-based, analytical methods such
as real-time PCR. QIAGEN Hamburg focuses on the development of
molecular diagnostic methods for the detection of infectious agents
as well as for pharmacogenetics and general genetics. QIAGEN Hamburg
was the first to bring a SARS detection test to the market in 2003.
Certain of the statements contained in this news release may be
considered forward-looking statements within the meaning of Section
27A of the U.S. Securities Act of 1933, as amended, and Section 21E
of the U.S. Securities Exchange Act of 1934, as amended. To the
extent that any of the statements contained herein relating to
QIAGEN's products, markets, strategy or operating results are
forward-looking, such statements are based on current expectations
that involve a number of uncertainties and risks. Such uncertainties
and risks include, but are not limited to, risks associated with
management of growth and international operations (including the
effects of currency fluctuations and risks of dependency on
logistics), variability of operating results, the commercial
development of the applied testing markets, clinical research markets
and proteomics markets, nucleic acid-based molecular diagnostics
market, and genetic vaccination and gene therapy markets,
competition, rapid or unexpected changes in technologies,
fluctuations in demand for QIAGEN's, products (including fluctuations
due to the level and timing of customers' funding, budgets, and other
factors), our ability to obtain regulatory approval of our infectious
disease panels, difficulties in successfully adapting QIAGEN's
products to integrated solutions and producing such products, the
ability of QIAGEN to identify and develop new products and to
differentiate its products from competitors' products, market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses. For further information, refer to the
discussions in reports that QIAGEN has filed with, or furnished to,
the U.S. Securities and Exchange Commission (SEC).
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Qiagen N.V.
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