First CE-marked automated nucleic acid purification system

Venlo/Netherlands – Qiagen has launched what it believes to be the world’s first CE-certified, automated sample preparation system for viral nucleic acids. The new BioRobot MDx DSP system fulfills the requirements of the EU’s Directive 98/79/EC on in-vitro diagnostics. When used with QIAamp DSP 96 Virus MDx consumables, the BioRobot MDx DSP provides efficient, automated purification of high-quality viral nucleic acids from human plasma or serum. 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 includes the instrument, software, service, purifications kits, and protocols that provide sample and data tracking and full process documentation. The major goals of the 98/79/EC Directive are to standardize diagnostic procedures within the European Union, increase reliability of diagnostic analysis and 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.