Qiagen gets emergency use authorization for COVID-19 test

Qiagen’s Qiastat-Dx syndromic testing solution (Qiagen photo)

Qiagen’s Qiastat-Dx syndromic testing solution (Qiagen photo)

A German firm that has its North American manufacturing, research and development facility in Germantown has received emergency use authorization from the Food and Drug Administration for its new test for the new coronavirus that causes COVID-19.

Qiagen Sciences announced the authorization Tuesday for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test, which it says can differentiate the new coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run that takes about one hour.

The new testing panel is intended for use in laboratories certified to perform moderate and high complexity tests and includes assays targeting two genes used to detect the pathogen behind the disease.

Thierry Bernard, CEO at Qiagen, said in a news release that the new test panel adds an important tool for clinicians, and that he is proud of the company’s teams working to implement round-the-clock production of test cartridges and testing parts.


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