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FDA COVID-19 Update

Authorizes the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing

By: Contract Pharma

Contract Pharma Staff

The U.S. FDA has taken the following action as of May 8 in the ongoing response effort to the COVID-19 pandemic:  The FDA authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously authorized under the high complexity molecular-based LDT “umbrella...

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