Thermo Fisher Scientific Completes CE-IVD Registration of its QuantStudio™ 5 Dx System
Product News Aug 08, 2017
Thermo Fisher Scientific newly announced the successful CE-IVD registration of its QuantStudio 5 Dx Real-Time PCR System for sale in European countries. The platform provides European customers with modern and user-friendly instrument that is designed to easily integrate into their existing diagnostic workflow. The product will be on exhibit in booth #4039 during the 2017 American Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo, being held July 31 – August 3 at the San Diego Convention Center.
"Many diagnostic qPCR instruments on the market today are dated. These older platforms do not leverage key advances in design that improve accuracy and the user experience", said Will Geist, vice president and general manager of qPCR for Thermo Fisher. "Today's molecular diagnostic laboratories and developers require high-performing qPCR systems that can be seamlessly adopted into their in-vitro diagnostic (IVD) work flow."
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.