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Qiagen Gets CE Mark for High-Capacity Syndromic Testing Platform

NEW YORK – Qiagen said on Monday that a higher-capacity version of its QiaStat-Dx automated syndromic testing system has received CE marking.

Accordingly, the company has commercially launched the platform, called QiaStat-Dx Rise, in Europe and other territories that recognize the CE mark.

The new platform builds on the existing QiaStat-Dx system by incorporating up to four additional analytical modules for a total of eight, enabling random-access capacity of up to 18 different tests. The system can provide diagnostic results for up to 56 tests in an eight-hour shift and 160 tests per day, Qiagen said.

The launch of the new platform "provides automated, comprehensive pathogen testing for higher-demand medical institutions," Jean-Pascal Viola, senior VP and head of the molecular diagnostics business area at Qiagen, said in a statement. "Crucially, QiaStat-Dx Rise is compatible with our updated QiaStat-Dx Respiratory SARS-CoV-2 Panel, the QiaStat-Dx Gastrointestinal Panel 2, as well as all of our future assays."

Qiagen also announced that its previously CE-marked QiaStat-Dx Respiratory Panel has been expanded to test for an additional target, Chlamydophila pneumoniae, bacteria that cause respiratory infections that can present with influenza-like symptoms, bringing the total number of viral and bacterial targets on the panel to 23.

In addition, Qiagen updated its CE-marked QiaStat-Dx Gastrointestinal Panel 2 with new features for improved sample preparation and panel performance, Qiagen said. The panel, which can detect and differentiate between 22 viral, bacterial, and parasitic targets that cause GI infections, can report the toxin content (stx1 and stx2) for Shiga-like toxin-producing Escherichia coli, information that can be used to determine the risk of certain patient populations to develop hemolytic uremic syndrome, Qiagen said.