Replies to post #83104 on Decision Diagnostics Corp (DECN)

[rawman]

If I'm reading this correctly, if there is an EUA it does not apply

Prior to May 4, any Company could distribute a COVID-19 antibody test after providing formal "NOTIFICATION" to the FDA and agreeing to abide the FDA disclaimers that were in place at the time. There was no requirement that the tests be granted an EUA Authorization. Ultimately, around 100 companies submitted a formal "NOTIFICATION" to the FDA.

Due to the fact, the actual results for a large number of antibody tests were deemed less than reliable, as of May 4, the FDA changed the rules. Moving forward, ANY test related to COVID-19 and distributed in the U.S. had be granted an EUA Authorization. The antibody tests, which had previously been distributed in the U.S., were granted 10 days to submit an EUA application.

For Immediate Release:

May 21, 2020

Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request.

On May 4, 2020, the FDA announced a revised guidance recommending that commercial manufacturers of antibody tests submit an EUA request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later. In keeping with the FDA’s commitment to transparency, today the agency is providing a list of antibody tests from commercial manufacturers that have been removed from the antibody test notification list. It is expected that this removal list will continue to be updated.

The FDA now requires ALL COVID-19 testing modalities to be granted an FDA EUA Authorization in order to be distributed in the U.S. There are no longer any exceptions. As of today, 76 companies and 29 laboratories have an EUA Authorization, with 13 of these FDA-qualified methodologies testing for COVID-19 antibodies. 62 companies provide molecular assays to diagnose active SARS-CoV2 infections.