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9th March 2020  Author: Paul Carton

FDA Recruit Covid-19 3rd-party Kit Manufacturers to Meet Demand


In the latest White House press briefing concerning test kits for Covid-19, FDA Commissioner Stephen Hahn informed the public that CDC's Covid-19 3rd-party kit manufacturers could have 4 million test kits available by the end of this week. The announcement comes amidst pressure on the FDA and CDC for not providing testing capacity nationwide that this outbreak demands. 

One of these 3rd party manufacturers, Integrated DNA Technologies (IDT), received authorisation from the US FDA last week, to provide public and non-public labs reagents to test for the SARS-CoV-2 virus. Hahn stated that IDT has another 400,000 tests which have undergone and passed final quality control check and that these are expected to be shipped out to laboratories on the 9th of March. 

Another manufacturer's tests will be undergoing a quality control check. That batch of 640,000 tests could also be shipped the same day.

Stephen Hahn also stated that all public health labs who received the original kits, the ones that couldn't be validated on receipt, have all now been sent out new kits. 


    

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Date Published: 9th March 2020

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