July 31, 2017
Thermo Fisher Scientific Completes CE-IVD Registration of its QuantStudio™ 5 Dx System for In Vitro Diagnostic Use in Europe
The QuantStudio 5 Dx has been designed to deliver an enhanced user experience with multi-modal software, enabling users to operate the instrument in either test-development, research use only (RUO) mode, or IVD mode. This modern, affordable, easy-to-use qPCR system lends itself ideally to clinics, hospitals and diagnostic test developers performing molecular biology testing using quantitative PCR.
The platform has seen strong adoption since its introduction. Siemens Healthineers and Thermo Fisher announced a strategic agreement focused on incorporating the QuantStudio 5 System into Siemens' Atellica® MDX 160 Molecular System to provide more flexibility and customization to its laboratory workflow. In addition, Seegene Inc. and Thermo Fisher jointly announced a collaborative partnership to seek clearance from the U.S. Food and Drug Administration (FDA) for Seegene's Allplex™ diagnostic assay portfolio on the QuantStudio 5 System, for which Thermo Fisher is seeking clearance in parallel.
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com
Last Updated: 2017.05.16