BioCentury
ARTICLE | Product Development

Asymptomatic COVID-19 testing reaches inflection point

U.S. policymakers and regulators usher in an era of more widespread and decentralized COVID-19 testing

December 19, 2020 3:38 AM UTC

With the pandemic raging, regulators are breaking down the distinction between symptomatic and asymptomatic COVID-19 testing, and opening the door to individual self-screening.

Communications from FDA and HHS, and the authorization of two home antigen tests this week, solidify the U.S.’s transition from a framework focused on clinical diagnosis of patients with symptoms to one that encourages asymptomatic screening, both on- and off-label. ...