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Thermo Fisher Scientific Gets CE-IVD Mark for QuantStudio Dx System

NEW YORK (GenomeWeb) – Thermo Fisher Scientific announced today that it has received CE-IVD marking for its QuantStudio 5 Dx Real-Time PCR system for sale in Europe.

The instrument's multi-modal software enables users to operate it in either test-development, research-use-only (RUO), or in vitro diagnostic (IVD) mode. Thermo said that the system is designed to benefit clinics, hospitals, and diagnostic test developers performing molecular biology testing using qPCR.

"Today's molecular diagnostic laboratories and developers require high-performing qPCR systems that can be seamlessly adopted into their IVD workflow" Will Geist, vice president and general manager of qPCR for Thermo Fisher, said in a statement.     

The company said that the platform has seen strong adoption since its introduction, but did not elaborate. Earlier this year, Thermo Fisher and Seegene jointly announced a collaboration to file for US Food and Drug Administration approval of Seegene's Allplex diagnostic assay portfolio on the QuantStudio 5 system. In addition, Siemens Healthineers and Thermo Fisher announced an agreement to focus on incorporating the QuantStudio 5 system into Siemen's Atellica MDX 160 Molecular System to provide flexibility and customization to its laboratory workflow.