QIAGEN Launches the World’s First CE-marked Nucleic Acid Purification Solution for Molecular Diagnostics
Venlo, The Netherlands, February 17, 2004 - QIAGEN, N.V. (Nasdaq: QGENF; Frankfurt, Prime Standard: QIA) today announced that it has launched the first CE-certified generic sample preparation kit fulfilling the requirements of the EU's recent in-vitro diagnostic directive. The newly developed QIAamp DSP DNA Blood Mini Kit 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 QIAamp DSP DNA Blood Mini Kit is the first in a series of broadly applicable sample preparation products by QIAGEN 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 7th 2003, all products and kits which are used for in vitro diagnostic applications and which are sold after this date have to be compliant with this Europeandirective. In addition to high risk products such as HIV testing systems (list A) or blood glucose testing systems (list B), nucleic acid purification products which are used in diagnostic workflows are affected by this new regulatory framework.
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 nucleic acid purification product," said Noel Doheny, QIAGEN's VP Solutions for Molecular Diagnostics." QIAGEN shows highest commitment to the in vitro diagnostic market and to its customers working in this area. The development and launch of this product allows diagnostic customers to select a product which offers them full compliance with the IVD-Directive, safety in regard to nucleic acid purification from blood and highest efficiency through easy integration into diagnostic workflows."
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. The Company 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, the Company 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 1,600 people worldwide. Further information on QIAGEN can be found at 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).
Peer M. Schatz
Dr. Solveigh Mähler