(Reuters) – German molecular testing company Qiagen NV <QIA.DE> said on Tuesday it has begun shipping its diagnostic test for COVID-19 to the United States.
The test kit, QIAstat-Dx Respiratory SARS-CoV-2 Panel, requires less than one minute for sample preparation and can deliver results in about one hour, the company said.
Shipments come under a new policy laid out by the U.S. Food and Drug Administration earlier this month to help accelerate the availability of coronavirus diagnostic tests, developed by laboratories and commercial manufacturers during the public health emergency.
The company intends to submit an application for the related Emergency Use Authorization to the FDA this week, Qiagen said. The test kit can differentiate the coronavirus from 20 other respiratory infections in patients who may have similar symptoms, in a single test run of about one hour.
Qiagen, which is being bought by Thermo Fisher Scientific <TMO.N> in an $11.5 billion deal, has already received ‘CE’ marking, a kind of fit-for-use certificate, for the diagnostic test in Europe on Wednesday.
(Reporting by Trisha Roy in Bengaluru; Editing by Vinay Dwivedi)