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

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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