QIAGEN Launches Advanced Diagnostic Tests for Detection of Influenza and Avian (Bird) Flu Virus
Company Expands Leading Molecular Diagnostics Portfolio with Human and Veterinary Applications
VENLO, The Netherlands, November 7, 2005 - QIAGEN N.V. (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA), a leading provider of solutions for molecular diagnostics today announced the global launch of two novel test kits for the detection of influenza and the avian flu virus (H5N1). These new and advanced tests for use in humans and animals expand the Company's current leading offering in this area and provide significant advantages:
- Breakthroughs in sensitivity and speed
- Broad detection of virus strains
- Integrated control mechanism to dramatically reduce false positives
- Most rapid molecular detection of H5 and H5N1 viruses - under 75 minutes
- First and only avian flu PCR (H5N1) test for animals with government approval
- Most widely used test since 2004 for veterinary, export/import and food safety.
The first newly added product is the artus TM Influenza/H5 kit. It combines a broad screening test, with a highly specific assay for the detection of characteristic nucleic acids (RNA) of avian flu (H5N1) virus strains. The highly sensitive test requires only small sample amounts of a patient's sputum, throat and nasal swabs, can detect an infection of influenza or avian flu (H5N1) virus in less than two hours and can be run on the widely available LightCycler instrument.
The second kit added to the portfolio is a specific avian flu (H5N1) molecular detection kit targeting veterinary, import/export control and quarantine needs. This assay was launched in 2004 in China by PG Biotech. QIAGEN announced its agreement to acquire PG Biotech, a leading molecular diagnostics company in China in September of this year. This molecular test is worldwide the first product approved by a governmental authority specifically to detect avian flu (H5N1) in animals. It is believed to be by far the most widely used test kit for this purpose in the world.
QIAGEN has also made available a number of protocols recommended by various government and other public sources to test for avian flu. These protocols have adopted QIAGEN components as the recommended and standard components.
"The launch of these novel products and the breadth of our product portfolio for avian flu diagnosis demonstrate our commitment to providing the leading solutions for containing and treating pathogen-originated diseases such as avian flu," said Peer M. Schatz, QIAGEN's Chief Executive Officer. We invest heavily in scientific excellence and combine this with extensive experience working with governments, customers and regulatory agencies. The successful and first-to-market launches in these areas are proof of the strength of QIAGEN's innovation which continues to be the driver for our market and technology leadership in molecular diagnostics."
"The availability of our rapid PCR-based molecular diagnostic solutions is critical at a time when fear of a pandemic may prompt individuals to rush into using anti-virals without having undergone the appropriate diagnosis. Physicians need precise information on the nature of an influenza infection when a patient presents with symptoms. Our tests will assist in determining the correct therapeutic strategy. We believe this is extremely important at a time when production of anti-virals may come under pressure as global demand increases," Dr. Joachim Schorr, Senior Vice President Global Research & Development added.
"Due to the high mutation rate and diversity of the avian flu virus, broad detection of all H5 strains is very important and a significant feature to our new artus TM Influenza/H5 detection kit. Following validation by a renowned research institution, the kit will now be disseminated to leading international institutions. The Company intends to publish results in leading scientific journals shortly," said Dr. Ulrich Spengler , managing director of QIAGEN ( Hamburg ) GmbH.
artus TM Influenza/H5 LC RT-PCR Kit
QIAGEN's artus TM Influenza/H5 LC RT-PCR Kit combines a broad screening test ( RealArt TM Influenza LC RT-PCR Kit) which detects all 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 provides a fully integrated solution for avian flu detection when combined with QIAGEN's purification technology for virus, RNA QIAamp ® . This combination and an integrated control system dramatically reduce the risk of false positives or negative results thus leading to increases in safety and reliability. During the development of the test the sequences of all H5N1 isolates known to date have been considered. The reliability of the general screening assay ( RealArt TM Influenza LC RT-PCR Kit) for all influenza A and B viruses has been validated by several internal and external studies, using among others, samples from the Center for Disease Control and Prevention (CDC, Atlanta/USA).
The artus TM Influenza/H5 LC RT-PCR Kit and RealArt TM Influenza LC RT PCR Kit are based on the real-time PCR technology. Both kits have been developed for the detection of influenza viruses in human samples using the LightCycler instrument. Contrary to the classical detection procedures for influenza viruses which require 7 to 14 days time for results, the specific and highly sensitive QIAGEN detection kit reduces the time to detection of the influenza or avian flu (H5N1) virus to less than two hours. The much shorter analysis time, in combination with highest levels of sensitivity and reliability, allows detection of the influenza virus at a very early stage.
PG Biotech Avian influenza Virus FQ-PCR Detection Kit
The highly efficient, sensitive and specific real-time PCR based kits can be used to detect Avian Influenza Virus in live poultry through anal and throat swabs, muscle or organ from dead animals, as well as serum or plasma samples. The Generic version of the real-time RT-PCR kit can detect all 15 subtypes (H1-H15) of Avian Influenza Virus A and is suitable for initial screening; the subtype H5, H7 and H9 specific versions can be used on generic tested positive samples subsequently to decide the viral subtypes.
The real-time RT-PCR detection methods for Avian Influenza Virus, jointly developed by QIAGEN PG Biotech and Beijing Entry-Exit Inspection and Quarantine, recently approved as the new National Standards by the China State Bureau of Quality and Technical Supervision (CSBTS) and China Association for Standardization (CAS).
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, China, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, Sweden, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products for molecular diagnostics and preanalytical sample preparation, 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 http://www.qiagen.com/.
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 obtaining government approval of the proposed acquisition, 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 and the integration of acquisitions of 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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