NEW YORK – Qiagen announced Thursday that it has obtained CE marking under Europe's In Vitro Diagnostic Regulation (IVDR) for its PCR-based QiaStat-Dx instruments and assays.
The new CE marking includes the QiaStat-Dx Analyzer and high-capacity QiaStat-Dx Rise as well as the gastrointestinal and respiratory panels that run on the systems.
"This certification under the new, more rigorous EU regulatory framework underscores our commitment to provide healthcare professionals with reliable and rapid syndromic testing solutions they can trust," Fernando Beils, senior VP and head of Qiagen's molecular diagnostics business area, said in a statement.
Under the IVDR framework, devices are assigned risk classes from A, meaning low risk, to D, meaning high risk.
The QiaStat-Dx Analyzer 2.0 and QiaStat-Dx Rise are classified as class A devices, while the QiaStat-Dx Gastrointestinal Panel 2 is classified as a class C device.
The QiaStat-Dx Respiratory Panel Plus is classified as a class D device, which the firm said highlights its capabilities to meet the highest regulatory thresholds in Europe.
The submission for IVDR certification of the QiaStat-Dx Meningitis/Encephalitis Panel is expected in the coming months, Qiagen said. The firm has so far transitioned more than 80 percent of 180 total products to the IVDR regulatory framework.
Qiagen got hold of the core technology of the QiaStat-Dx through its acquisition of Spanish molecular diagnostics company Stat-Dx in early 2018 for up to $191 million. The system and accompanying respiratory pathogen panel already had CE marking and was commercially available in Europe along with a gastrointestinal pathogen panel.