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QIAGEN Gets CE Nod for QIAstat-Dx Respiratory SARS-CoV-2 Test

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QIAGEN N.V. (QGEN - Free Report) recently attained CE marking for its newly-developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (IVD) test for SARS-CoV-2, the virus responsible for COVID-19.

The regulatory clearance has made the company a key player in coronavirus diagnosis.

More About the Test

As the first syndromic testing solution launched in the European Union amid the coronavirus pandemic, the QIAstat-Dx test kit is equipped to distinguish the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may be suffering from similar symptoms in a single testing run of about an hour.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test that assesses samples such as nasopharyngeal swabs extracted from people suspected of respiratory tract infections. The newly-approved panel comprises assays targeting two genes which are used in the detection of SARS-CoV-2.


In addition to QIAstat-Dx, the company is offering RNA extraction kits under the QIAamp and EZ1 brands that have been recommended per the current global testing guidelines. The company is also providing several components and instruments that can be utilized in combating this public health crisis.

Other Companies Working on Coronavirus Testing

A number of diagnostic testing companies have now come up with manufacturing tests for the detection of SARS-CoV-2.

Among them, Thermo Fisher (TMO - Free Report) recently attained emergency use authorization (EUA) from the FDA for its diagnostic test to be used immediately by CLIA high-complexity laboratories in the United States. The test has been developed for the detection of nucleic acid exclusively from SARS-CoV-2.

Quest Diagnostics (DGX - Free Report) recently announced that it is set to launch a COVID-19 test service. This test would facilitate the potential detection of nucleic acid in respiratory specimens of patients who fulfill CDC's clinical criteria for COVID-19 testing. However, the FDA’s review under EUA is still pending.

LabCorp (LH - Free Report) ) recently launched its 2019 novel coronavirus NAA test in the United States. The test should benefit patients who meet current guidelines for evaluation of the disease.

Price Performance

In the past six months, the company’s shares have outperformed the industry. The stock has rallied 14% against the industry’s 4.4% decline.

Zacks Rank and Key Picks

QIAGEN currently has a Zacks Rank # 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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