SARS-CoV-2 Reference Panel Comparative Data | FDA

SARS-CoV-2 Reference Panel Comparative Data | FDA

Coronavirus (COVID-19) Update: Daily Roundup September 30, 2020

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• Today, the U.S. Food and Drug Administration (FDA) updated the SARS CoV-2 reference panel comparative data on FDA’s website to reflect the latest information. The FDA SARS-CoV-2 reference panel is a standardized performance validation step for authorized SARS-CoV-2 molecular diagnostic tests. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The FDA intends to continue to update the tables on the website.
• As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Tonic Therapeutic Herb Shop & Elixir Bar for selling unapproved products with fraudulent COVID-19 claims. The company sells various herbal products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Tonic Therapeutic Herb Shop & Elixir Bar, immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
• In a new FDA Voices entitled, A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response, FDA Commissioner Stephen M. Hahn, M.D. highlights how in just a few short months, the agency’s Center for Devices and Radiological Health’s response to the pandemic has been unprecedented in terms of volume, speed and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment and extensive engagement with stakeholders.

The FDA also posted an infographic that provides a visualization of data associated with CDRH's response to the coronavirus (COVID-19) pandemic.

• Testing updates:
  • As of today, 263 tests are authorized by FDA under EUAs; these include 208 molecular tests, 51 antibody tests, and 4 antigen tests.