Firms and Federal Labs Flock to FDA Seeking Emergency Use Authorization for Ebola MDx Assays | GenomeWeb

NEW YORK (GenomeWeb) ― At least five companies have indicated they will pursue or are considering pursuing Emergency Use Authorization from the US Food and Drug Administration to make nucleic acid tests for Ebola available, while three RT-PCR assays have already been granted EUA since an emergency was declared in early August.

The three real-time RT-PCR tests that have already been granted EUA ― one from the US Department of Defense, and two from the US Centers of Disease Control ― can now be legally used to diagnose patients.

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