PreAnalytiX PAXgene™ Blood RNA System is Industry’s First to Receive 510(K) Clearance From FDA and to Attain CE Mark
System Cleared Through FDA's "De Novo" Classification Process
Franklin Lakes, NJ and Hombrechtikon, Switzerland, May 18, 2005 - PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company), (NYSE: BDX) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and attained CE mark for PreAnalytiX PAXgene Ô Blood RNA System. In addition, PreAnalytiX Quality System received ISO 9001: 2000 and EN ISO 13485: 2003 certification from the Notified Body TÜV.
The PAXgene Blood RNA system is the first of its class for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of intracellular RNA from whole blood for Reverse Transcription-Polymerase Chain Reaction (RT-PCR) used in molecular diagnostic testing. The PAXgene Blood RNA system was cleared according to the FDA "de novo" classification process whereby the system was determined to be safe and effective, and will be listed within the U.S. Federal Register as a new Class II device.
"We are enthused to be bringing this innovation to the market and particularly pleased that the PAXgene system is the only integrated system of its kind that has attained both FDA 510(k) clearance and CE marking, setting the standard for the diagnostic industry and moving RNA testing into routine clinical diagnostics," said William A. Kozy, President, BD Diagnostics.
"This "de novo" classification represents a giant step forward to enable pharmocogenomic studies and the advancement of personalized medicine. An accurate picture of in vivo gene expression profiles is essential for understanding gene regulation as it relates to different disease states and a patient's response to drug therapy," said Noel Doheny, Vice President of PreAnalytiX and QIAGEN. "The PAXgene system standardizes the entire preanalytical process from sample collection to stabilization and purification of RNA for whole blood gene expression profiling."
"The PAXgene Blood RNA system has significantly enhanced our ability to detect messenger RNA," said Daniel J. O'Shannessy, Ph.D., chief operating officer at Targeted Diagnostics & Therapeutics, Inc. "The stability of the RNA afforded by the PAXgene system allows us to receive blood samples from across the US and internationally into our laboratory in Pennsylvania . We applaud PreAnalytiX for the development and consistent quality of this product."
The PAXgene system has potential for many clinical applications that require stabilized intra cellular RNA. It is a key component of numerous diagnostic products in clinical trials as well as an important solution enabling areas such as clinical research, pharmacogenomics and toxicogenomics in research, drug discovery and development. In the future, the PAXgene Blood RNA System may be an enabling tool for clinicians to monitor therapy effectiveness and disease progression.
About the PAXgene Blood RNA System
The PAXgene Blood RNA System is an enabling technology that consolidates and integrates the key steps of whole blood collection, nucleic acid stabilization, and RNA purification. By minimizing the unpredictability associated with RNA processing, the system, composed of a blood collection tube and a nucleic acid processing kit, provides enhanced accuracy, greater efficiencies and reduced costs of intracellular RNA analysis.
The PAXgene blood collection tube is standardized on convenient BD Vacutainer Ò technology, enhancing patient and health care worker safety, providing sample protection, and facilitating consistent blood volumes.
The PAXgene blood collection tube contains a proprietary reagent developed by QIAGEN that immediately stabilizes intracellular RNA for three days at room temperature and up to six months at -20 degrees Celsius. The ability to eliminate freezing, batch samples, and minimize processing urgency greatly enhances lab efficiency.
The PAXgene kit uses a unique version of QIAGEN's proven separation and purification technology. The purification process is designed to provide high quality RNA from samples that have been stabilized in the PreAnalytiX reagent.
The PAXgene system provides customers (clinical laboratories, pharmaceutical, CRO, research institutions, etc.) with a completely integrated approach to RNA purification. No special kits. No uncertainty. One integrated product - from blood collection to high quality RNA.
About PreAnalytiX, GmbH
PreAnalytiX was formed in 1999 by QIAGEN and BD with the purpose of developing, manufacturing, and marketing integrated systems for the collection, stabilization, and purification of nucleic acids (DNA and RNA) for molecular diagnostic testing. More information about PreAnalytiX and the PAXgene Blood RNA System can be found at http://www.preanalytix.com/.
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, Sweden, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products 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 1,300 people worldwide. Further information on QIAGEN can be found at http://www.qiagen.com/.
BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 30, 2004, BD reported total revenues of $4.935 billion.
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, BD's or PreAnalytiX' products and markets and operating results are forward-looking, such statements are based on current expectations of their respective managements, which expectations 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 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, BD's or PreAnalytiX' products ( including fluctuations for certain events including funding, budgets, and others ), difficulties in successfully adapting products to integrated solutions and producing such products, the ability to identify and develop new products and to differentiate its products from competitors, market acceptance of new products and the integration of acquisitions of technologies and businesses. For further information with respect to QIAGEN, refer to the discussion in reports that QIAGEN has filed with the U.S. Securities and Exchange Commission (SEC). Reference is also made to the other risks and uncertainties detailed from time to time in BD's filings with the SEC. QIAGEN, BD and PreAnalytiX do not intend to update any forward-looking statements.
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