FDA creates umbrella emergency pathway for COVID-19 serology tests

The US Food and Drug Administration (FDA) has created a new pathway to support the emergency authorization of tests for antibodies of the virus that causes COVID-19.

Serology tests could play an important role in the safe lifting of lockdowns by enabling authorities to identify individuals with antibodies of the SARS-CoV-2 virus and calculate what proportion of a population has already been infected. The pathway unveiled by FDA on Wednesday gives test developers a new route to an emergency use authorization (EUA).