On March 11, 2020, the World Health Organization declared covid-19 a pandemic. The President of the United States declared a national emergency on March 13, 2020, in response to the covid-19 outbreak in the United States. The public health emergency has led FDA to issue an unprecedented number of emergency use authorizations (EUAs) for covid-19 diagnostic tests.

In response to the covid-19 pandemic, FDA—in collaboration with the Centers for Disease Control and Prevention, the Biodefense and Emerging Infections Research Resources Repository, the Institute for Genome Sciences at the University of Maryland, and the National Center for Biotechnology Information at the National Institutes of Health—has developed quality-controlled reference sequence data for the SARS-CoV-2 reference strain for the United States.

Availability of traceable and quality-controlled data will help test developers and vaccine developers:

  • Expedite development of medical countermeasures.
  • Identify new or more stable targets for future tests.
  • Enable in silico confirmation of targets.
  • Support development of synthetic reference material.
  • Enable viral population/quasi species analysis.

Read more from FDA.

Featured image: Colorized scanning electron micrograph of an apoptotic cell (purple) heavily infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility in Fort Detrick, Maryland. Photo courtesy NIAID.