|
 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.
[to top of second column] |
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)
[© 2020 Thomson Reuters. All rights
reserved.] Copyright 2020 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |
