The U.S. Department of Health and Human Services (HHS) will partner with Qiagen LLC of Germantown, Maryland, to accelerate development of a diagnostic test for the 2019 novel coronavirus (SARS-CoV-2). This easy-to-use test can provide results in about one hour.
The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response is providing technical assistance and $598,000 to accelerate the development of the QIAstat-Dx Respiratory SARS-CoV-2 Panel test. Qiagen will, under a costs share, provide the remaining funds for the development of this diagnostic test.
Qiagen will develop QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel that is currently FDA-cleared to test for 21 respiratory pathogens. The test kit can differentiate the SARS-CoV-2 coronavirus from other serious respiratory infections in patients who may have similar symptoms in a single testing run. The device features easy-to-use molecular testing with novel workflows.
The COVID-19 test could be ready within weeks for Emergency Use Authorization (EUA) consideration by the U.S. Food and Drug Administration (FDA). As of March 18, 2020, Qiagen’s test kit obtained CE marking as an in vitro diagnostic (IVD) in the European Union and obtained approval in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About the Company
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics).