(Newsletter) COVID-19 TESTING UPDATE – We Are Not Quite There Yet

By now, you have all been bombarded with offers for COVID-19 testing from medical suppliers. 

What’s going on? 

The Food and Drug Administration (FDA) has a process for approving new laboratory tests. During the pandemic, an Emergency Use Authorization (EUA) pathway was created to fast track approval for COVID-19 tests. On March 16, the FDA allowed commercial manufacturers to begin distributing tests under certain circumstances prior to granting an EUA1. They specifically allowed serological tests to identify antibodies to SARS-CoV-2 (COVID-19) to be distributed with some required disclaimers.

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