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, ResPlexTM I Panel, ResPlexTM II Panel and StaphPlexTM 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.
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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