The Biden Administration Initiates New Plan for National COVID-19 Testing

As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a new president takes office in the midst of a pandemic, that impact becomes not only magnified but also more immediate. This is particularly true when the new president’s views are diametrically opposed to those of his/her predecessor. The most dramatic illustration of these principles occurred on Jan. 20, 2021, the Biden administration’s first day in office, with the rollout of a bold new plan for COVID-19 testing called the National Strategy for COVID-19 Response and Pandemic Preparedness (National Strategy). The Diagnostic Challenge Back on Jan. 20, 2020, COVID-19 coronavirus was only just beginning to transform from an Asian to global threat. Because the virus was novel, there was no proven laboratory test to diagnose it. In late February, the U.S. declared a public health emergency and the U.S. Centers for Disease Control and Prevention (CDC) secured the first ever Food and Drug Administration (FDA) emergency use authorization (EUA) for a test to detect the coronavirus. However, as we would learn later, the CDC assay was seriously flawed. […]