QIAGEN Launches the World’s First CE-marked Fully Automated Nucleic Acid Purification System for Molecular Diagnostics
Venlo , The Netherlands, October 25, 2004 - QIAGEN, N.V. (Nasdaq: QGENF; Frankfurt , Prime Standard: QIA) today announced that it has launched the what it believed is the world's first CE-certified, automated sample preparation system for viral nucleic acids. The CE-marked BioRobot MDx DSP system fulfills the requirements of the EU's recent in-vitro diagnostic directive. The newly developed BioRobot MDx DSP system, running the QIAamp DSP 96 Virus MDx consumables, provides efficient, automated and walk-away purification of high-quality viral nucleic acids from human plasma or serum. The CE-marked system includes the instrument, software, service, purifications kits, and protocols that provide sample and data tracking and full process documentation.
Viral nucleic acids prepared on the BioRobot MDx DSP system are ready to use in broad range of sensitive diagnostic assays, based on technologies such as PCR and RT-PCR. The system is available for the European markets and is developed, produced and quality controlled according to all requirements of the CE in-vitro diagnostic directive. The BioRobot MDx DSP, with the QIAamp DSP 96 Virus MDx Kit is a further and significant addition to QIAGEN's portfolio of broadly applicable sample preparation products intended for use in molecular diagnostic testing.
Since the European Union Directive 98/79/EC on in vitro diagnostic medical devices went into effect on December 7 th 2003, all products and kits which are sold for use for in vitro diagnostic applications have to be compliant with this European directive.
The major goals of this CE directive are to standardize the diagnostic procedures within the European Union, to increase reliability of diagnostic analysis and to enhance patients´ safety through the highest level of product safety. These goals are expected to be achieved by the enactment of a large number of mandatory regulations for product development, production, quality control and life cycle surveillance.
"QIAGEN is once again setting standards by launching the first CE-marked, stand-alone and automated sample preparation system for viral nucleic acids" said Noel Doheny, QIAGEN's VP Solutions for Molecular Diagnostics. "QIAGEN has full commitment to the in vitro diagnostic market and to its customers working in this area. The development and launch of this system allows diagnostic customers to select a product which offers them full compliance with the IVD-Directive, assuring highly reliable purification procedures in regard to viral nucleic acid purification from human plasma and serum and highest efficiency through easy integration into diagnostic workflows."
"The CE-marked BioRobot MDx System encompasses new and state-of-the-art technology. It is a totally revamped and new system based on QIAGENs BioRobot MDx. QIAGEN has launched a number of products this year designed and validated for diagnostic use and expects to continue to expand this portfolio significantly," added QIAGEN's Senior Vice President Global R&D Dr. Joachim Schorr. "It represents the third CE-marked product developed and introduced in 2004 by QIAGEN. QIAGEN's CE-marked products leverage new and leading technologies to set new standards for customers working in regulated environments."
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 , 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. QIAGEN has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid 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 DNA sequencing and genomics, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs approximately 1,400 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 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 DNA sequencing, genomics and synthetic nucleic acid-related 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 seasonal fluctuations), 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, and the integration of acquisitions of technologies and businesses. For further information, refer to the discussion in reports that QIAGEN has filed with the U.S. Securities and Exchange Commission (SEC).
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