CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific today 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 proven Ion Torrent next generation sequencing (NGS) technology, currently used to produce hundreds of 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,” said 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.”
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“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,” said 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.”
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