NEW YORK – Despite intense scrutiny and criticism of the diagnostic testing rollout in the US for the SARS-CoV-2 virus, the emergency regulatory process may actually be proceeding at a much more rapid pace than past emergencies, which did not involve newly-emerged pathogens.
Commercial tests in development to date have faced bottlenecks in test validation, but the logjam now appears to be clearing with new US Food and Drug Administration feedback and the availability of control materials.