QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced 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 will submit this week the related Emergency Use Authorization (EUA) to the FDA.
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.
“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,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “Our teams have responded rapidly to the challenge, implementing 24/7 production of test components, adding staff and investing in expanding production capacity. In addition to QIAstat-Dx, we are supplying RNA extraction kits to the U.S. and other countries around the world, and are committed to accelerating these efforts.”