QIAGEN Launches the World's First CE-marked Nucleic Acid Purification Solution for Molecular Diagnostics

18-Feb-2004

Venlo, The Netherlands. QIAGEN, N.V. 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 European directive. 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 [proceedings-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."

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