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Re: JJ24 post# 185764

Monday, 03/30/2020 12:40:47 PM

Monday, March 30, 2020 12:40:47 PM

Post# of 205090
<< https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19 >>

That statement by the FDA is specifically talking about diagnostic tests (aka PCR / swab tests), which look for viral samples.

It has nothing to do with serologic / blood tests (which is supposedly what ARYC is working on), which look for antibodies.

"Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed."



"Developing a test:

Typically, with an emerging health threat, the Centers for Disease Control and Prevention (CDC) is the first developer of a diagnostic test in the U.S. - Samples of the virus are crucial to confirming the accuracy of the test.
CDC has first access to viral samples that other test developers do not. CDC also manufactures their own tests for distribution to their national network of public health labs. In this pandemic, CDC encountered problems manufacturing their test. FDA assisted CDC in their work to resolve the issue and utilize a commercial manufacturer to make tests for any laboratory, not only public health labs.
Viral samples became commercially available to private sector test developers in later February, when the National Institutes of Health’s partner BEI Resources began selling vials of the virus grown from material provided by CDC.
Laboratories have always had the ability to develop their own tests in the U.S.; the COVID-19 outbreak did not change this. Once a developer has a viral sample, they can confirm the accuracy of their test very quickly, usually in two to three days.
In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly. Moreover, CDC’s test should be manufactured by a commercial entity with the requisite expertise."