QIAGEN launches QIAstat-Dx test kit for detection of SARS-CoV-2 coronavirus in Europe following CE marking

March 18, 2020 |

2 min read

First syndromic testing solution to obtain CE marking as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2 , and is now available for purchase in the European Union

March 18, 2020 23:00 UTC

First syndromic testing solution to obtain CE marking as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2 , and is now available for purchase in the European Union
QIAstat-Dx Respiratory SARS-CoV-2 Panel deployed in pandemic can differentiate novel coronavirus from 21 other serious respiratory infections with one sample and delivers results in about one hour
Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response

GERMANTOWN, Maryland & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has obtained CE marking for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2.

As the first syndromic testing solution in the European Union for use in the coronavirus epidemic, the QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2).

“We are pleased to launch the QIAstat-Dx SARS-CoV-2 test kits in Europe for clinical laboratories. QIAGEN is partnering with customers and public health authorities worldwide to provide a wide range of testing workflows, and the QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Interim CEO and Senior Vice President, Head of the Molecular Diagnostics Business at QIAGEN. “Our QIAGEN teams have responded rapidly to the spread of the COVID-19 disease, implementing 24/7 production of test components, adding staff and investing in expanding production capacity. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands that have been recommended in current testing guidelines worldwide, as well as numerous components and instruments for use in fighting this public health crisis.”

Please find the full press release here

A video on QIAstat-Dx can be found here

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.