Qiagen launches EU-approved NA purification system
system for viral nucleic acids to aid molecular diagnostics that
conforms to a European Union Directive on in vitro diagnostic
medical devices.
Qiagen's newly developed Biorobot MDx DSP system, when running the QIAmp DSP 96 Virus MDx consumables, provides purification of high-quality viral nucleic acids from human plasma or serum.
The system includes the instrument, software, service, purification kits, and protocols that provide sample and data tracking and full process documentation.
Viral nucleic acids prepared on the system are ready to use in a broad range of sensitive diagnostic assays, based on technologies such as PCR and RT-PCR. 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.
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 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 sold for use for in vitro diagnostic applications, have to be compliant with this European directive.
With almost two-thirds of the market, Qiagen continues to dominate the DNA purification kit market. The company's success can be attributed to many factors including their strong focus on the nucleic acid purification market, first-mover advantage and broad product offering.
Qiagen is the first company to launch the first CE-marked, stand-alone and automated sample preparation system for viral nucleic acids. It forms part of Qiagen's overall strategy, adding to the molecular diagnostics market and boosting development of standardised and solutions in these emerging and rapidly growing markets.
Noel Doheny, Qiagen's VP solutions for molecular diagnostics said: "The development and launch of this system allows full compliance with the IVD-Directive, assuring reliable purification procedures in regard to viral nucleic acid purification from human plasma and serum and efficiency through integration into diagnostic workflows."
Qiagen's launch of this product is a response to the industry and the emergence of diagnostic technology that will need the inclusion of fully automated ultra high-throughput sample preparation systems.
Other players on the market have recently included Fuji Photo Film's Quickgene 800. Tepnel Life Sciences' Nucleopure DNA purification system, which is used for the extraction, recovery and purification of high yields of highly intact genomic DNA from a range of tissues, has been met with a considerable success.
According to a study published by Bioinformatics, the market for protein and DNA purification kits is maturing, and the pace of technological innovation has slowed, leaving dozens of companies fighting for market share.
The report stated that companies with complete protein purification systems reap the rewards of unified technologies in their ability to maintain their customer base throughout all areas of the value chain.
