NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that its Ion PGM Dx System has been CE-IVD marked for sale in Europe.
The system was developed using Ion Torrent next-generation sequencing technology and was validated using "challenging" germline variants with library kits based on the Ion AmpliSeq technology. The Ion PGM Dx System includes the instrument, GMP reagents, and software controls to establish high-performing next-generation clinical sequencing workflows, Thermo Fisher said.
The company is accepting orders for the platform in Europe and plans to begin fulfilling them later this year.
CE-IVD registration of the system will allow clinical laboratories in Europe to more easily develop and implement NGS-based diagnostic assays in accordance with the European Directive on In Vitro Diagnostic Medical Devices, Mark Stevenson, president of Life Sciences Solutions at Thermo Fisher, said in a statement. The system provides accurate genetic variant analysis using as little as 10 ng of sample DNA and provides the rapid turnaround time needed in a clinical setting, he added.