Thermo Fisher Scientific's Ion PGM Dx system is CE-marked for in vitro diagnostic use

Thermo Fisher Scientific has announced the successful CE-IVD registration of its new Ion PGM Dx system for sale in European countries. The Ion PGM Dx system was developed using the Ion Torrent next generation sequencing (NGS) technology, currently used to produce thousands of tests in clinical research laboratories each year to uncover meaningful genetic information for a range of human conditions.

“The CE-IVD registration of the Ion PGM Dx System will enable European clinical laboratories to more easily develop and implement new next generation sequencing diagnostic assays in accordance with the European Directive on In Vitro Diagnostic Medical Devices,” says Mark Stevenson, president of life sciences solutions at Thermo Fisher Scientific. “Providing accurate and reliable genetic variant analysis with as little as 10ng of sample DNA, and with the rapid turnaround times required in clinical settings, we anticipate the Ion PGM Dx will bring many benefits to the European clinical and diagnostic communities.”

The Ion PGM Dx System was validated using a number of challenging germ line variants with library kits based on the Ion AmpliSeq technology. To support the accuracy and reproducibility performance requirements of clinical laboratories, the complete Ion PGM Dx System includes the instruments, GMP reagents, and software controls necessary to establish high-performing next generation clinical sequencing workflows. Learn more about the Ion PGM Dx.