German molecular testing company Qiagen NV said on March 24 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 (FDA) earlier this month to help accelerate the availability of CCP (Chinese Communist Party) virus 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 CCP virus 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 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.
NTD refers to the novel coronavirus, which causes the disease COVID-19, as the CCP virus because the Chinese Communist Party’s coverup and mismanagement allowed the virus to spread throughout China and create a global pandemic.
By Trisha Roy in Bengaluru
NTD staff contributed to this report.
