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Qiagen Syndromic Testing System, Respiratory Panel Garner FDA Clearance

NEW YORK (GenomeWeb) – Qiagen said today that its QiaStat-Dx syndromic testing system and multiplex respiratory pathogen panel have received 510(k) clearance from the US Food and Drug Administration.

With the clearance, Qiagen is commercially launching the products in the US, the company said.

The QiaStat-Dx system features multiplexed real-time PCR and can detect as many as 48 targets simultaneously, enabled by a proprietary microfluidic test cassette design and a six-wavelength optical sensor. The system will also be capable of running immunoassays using time-resolved fluorescence.

Qiagen acquired the technology along with 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 is commercially available in Europe. A gastrointestinal pathogen panel is also available in Europe.

The QiaStat-Dx Respiratory Panel simultaneously and qualitatively detects and identifies more than 20 respiratory viral and bacterial pathogens. The panel is the first in a pipeline of planned assays for the QiaStat-Dx system in the US, with a gastrointestinal pathogen panel anticipated later this year. Qiagen said it is also developing assays for other infectious disease indications, oncology, and companion diagnostics.

"We are pleased to roll out the QiaStat-Dx Respiratory Panel for healthcare providers as they begin to prepare for the 2019-20 flu season," Thierry Bernard, senior vice president and head of Molecular diagnostics for Qiagen, said in a statement. 

In morning trading on the New York Stock Exchange Qiagen's shares were up nearly 4 percent to $38.41.