The FDA granted an emergency use authorization to Qiagen (NYSE:QGEN) for a diagnostic test that the company said can differentiate among COVID-19 and 20 other respiratory diseases that cause similar symptoms, the company said today.
The SARS-CoV-2 Panel test works in about an hour, according to Netherlands-based Qiagen. It is a multiplexed nucleic acid test that includes assays targeting two genes used to detect the pathogen behind COVID-19. The company began shipping the tests to the U.S. earlier this week under a new FDA policy allowing the kits to be made commercially available.
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. Qiagen chemistries for DNA and RNA sample processing and analysis are built into the instrument, according to the company.
“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 Qiagen CEO Thierry Bernard in a news release. “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.”