QIAGEN Products Adopted by Major Testing Centers Worldwide for Use in Avian Flu Surveillance
Venlo, The Netherlands, February 13, 2006 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), a leading provider of molecular diagnostics products and the world's premier supplier of solutions for preanalytical sample preparation, today announced rapid adoption of its broad product portfolio in avian flu (H5N1) detection and surveillance by major testing centers worldwide.
In a survey conducted at year-end 2005, QIAGEN has established that m ore than 80 institutions are now using QIAGEN preanalytical products and test kits as standard tools in their surveillance programs. QIAGEN believes that this represents a significant majority of all institutions involved in the global monitoring of this virus, making QIAGEN the leading provider of molecular assays and preanalytical and assay components for avian flu.
Tests for the avian flu (H5N1) virus using QIAGEN tools are highly specific, sensitive and fast. Subject to local regulatory requirements, they address both human and veterinary applications. The assays are based on real-time PCR and include assays that detect H5 and H5N1 viruses within 75 minutes, with very high analytical sensitivity.
"As the incidence of H5N1 begins to spread to more and more countries, it is increasingly important that tools are available to detect and monitor the virus quickly and efficiently. Our product portfolio for avian flu has been swiftly developed and deployed in the response to this global threat," said Peer M. Schatz, QIAGEN's Chief Executive Officer. "In 2003, our Hamburg team was also the first to launch a molecular assay for SARS. This is now a further example of how QIAGEN's technology leadership in solutions for pathogen testing has allowed us to act so rapidly and has a direct and significant impact in addressing this pandemic threat."
About the Tests:
QIAGEN's portfolio includes a specific avian flu (H5N1) detection kit targeting veterinary, import/export control and quarantine needs. This test was launched in 2004 in Asia and was the first product approved by a governmental authority specifically to detect avian flu (H5N1) in animals. The real-time RT-PCR detection methods for Avian Influenza Virus, jointly developed with the Beijing Entry-Exit Inspection and Quarantine, was approved as the new National Standards by the China State Bureau of Quality and Technical Supervision (CSBTS) and China Association for Standardization (CAS) for the Chinese markets in late 2005.
QIAGEN's artus TM Influenza/H5 LC RT-PCR Kit is a specific, sensitive and fast test of avian virus and combines a broad screening test ( RealArt TM Influenza LC RT-PCR Kit) which detects both influenza A and B viruses, with a highly specific detection of characteristic nucleic acids (RNA) of avian flu (H5N1) virus strains.
The test comes in a ready to use master mix format and can be combined with QIAGEN's purification technology for virus RNA QIAamp ® . This combination and an integrated control system dramatically reduce the risk of false results. During the development of the assay the sequences of all H5N1 isolates known to date have been considered.
In addition, a number of protocols recommended by various government agencies to test for avian flu in animals and humans have adopted QIAGEN tools as standard components.
QIAGEN's influenza detection products are for research use only. They have not been cleared or approved by authorities including the United States Food and Drug Administration or any other regulatory agency in the United States, or under the European IVD Directive, for human diagnostic or other clinical use, and are not intended and should not be used for human diagnostic or any other clinical purposes.
QIAGEN N.V., a Netherlands holding company with subsidiaries in Germany, the United States, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, China, Malaysia, Sweden, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products for molecular diagnostics solutions and preanalytical sample preparation for the separation, purification and handling of nucleic acids and proteins. QIAGEN has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid and protein separation, purification and handling, nucleic acid amplification, as well as automated instrumentation, synthetic nucleic acid products and related services. QIAGEN's products are sold in more than 42 countries throughout the world to academic research markets and to leading pharmaceutical and biotechnology companies. In addition, QIAGEN is positioning its products for sale into developing commercial markets, including applied testing markets, clinical research, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs more than 1,500 people worldwide. Further information on QIAGEN can be found at www.qiagen..
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 ), 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, the integration of acquisitions of technologies and businesses, and the timing of product introductions by our commercial partners. 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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