Health Affairs August 18, 2020
Availability of accurate diagnostics is critical to an effective pandemic response. Tests are needed to guide public health decision-making, to help contain community transmission, and to help health systems with care planning and resource allocation. However, because SARS-CoV-2 was a novel pathogen, there was not a readily available diagnostic when the virus first reached the United States. Furthermore, as COVID-19 spread across the country, demand for testing soon outpaced the capacity of the nation’s public health laboratory system.
The Food and Drug Administration (FDA) has sought to expedite access to COVID-19 diagnostics by issuing Emergency Use Authorizations (EUAs) and providing regulatory flexibilities to commercial and laboratory developers. However, FDA has encountered challenges in this work, including some developers’ lack of...
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