QIAGEN Receives US FDA EUA for First and Only Syndromic Coronavirus Test

QIAGEN (Hilden, Germany) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The EUA approval status comes after QIAGEN recently began shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.

QIAGEN provides Sample to Insight solutions in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) to customers around the world. The company has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories. The automation system enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for DNA and RNA sample processing and analysis are built into the instrument, and the QIAstat-Dx instrument delivers results in about one hour.

QIAGEN’s QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from two other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It 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), and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.

“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States under the FDA’s emergency use authorization for clinical laboratories. The QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Chief Executive Officer at QIAGEN. “I am proud of our QIAGEN teams working tirelessly to implement 24/7 production of test cartridges and testing components. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands as well as numerous components and instruments for use in fighting this public health crisis around the world.”

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