HHS-funded QIAGEN ships COVID-19 tests to the US

German company QIAGEN announced last week that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and Drug Administration (FDA) announced on March 16. QIAGEN also said it would file for an Emergency Use Authorization (EUA) from the FDA.

The release of this new QIAstat-Dx test also comes after it was announced on March 13, 2020, that QIAGEN received funding for this project in part from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No 75A50120C00014.

The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 20 other 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. This new panel includes assays targeting two genes used to detect SARS-CoV-2, the pathogen behind the disease.

QIAGEN began shipping QIAstat-Dx SARS-CoV-2 test kits to other countries in February 2020 for clinical validation and has dramatically ramped up production of the respiratory panels. The kits run on QIAstat-Dx instruments, QIAGEN’s Sample to Insight syndromic system that automates molecular analysis to deliver differential diagnosis in about one hour. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories, including over 200 in the U.S. since FDA clearance of the QIAstat-Dx Analyzer was granted in May 2019.

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.

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