March 24, 2020—Qiagen has started shipping its QIAstat-Dx Respiratory SARS-CoV-2 Panel test to the United States under an FDA policy announced on March 16. Qiagen will submit this week the related emergency use authorization to the FDA.
“We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States as the first syndromic test not only to detect SARS-CoV-2, but also a range of more than 20 other respiratory targets. This is an important step in our commitment to offer a range of solutions to support the public health fight against COVID-19 and dramatically ramp up production,” Thierry Bernard, chief executive officer of Qiagen, said in a press release.
The QIAstat-Dx is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. This panel includes assays targeting two genes used to detect SARS-CoV-2.