U.S. flag An official website of the United States government
  1. Home
  2. News & Events
  3. FDA Newsroom
  4. Press Announcements
  5. Coronavirus (COVID-19) Update: Daily Roundup June 12, 2020
  1. Press Announcements

FDA News Release

Coronavirus (COVID-19) Update: Daily Roundup June 12, 2020

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.’s Cue COVID-19 Test. This test is authorized for use at the Point of Care, that is, in patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Point-of-care testing means that results are delivered to patients in patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. This approach gives patients more immediate access to test results.
  • The FDA issued a warning letter to EUCYT Laboratories, LLC, for, among other things, marketing an unapproved exosome product for the treatment or prevention of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19.
  • Testing updates:
    • To date, the FDA has authorized 135 tests under EUAs, which include 114 molecular tests, 20 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###


Inquiries

Media:
Lee Herring
240-402-6386
Consumer:
888-INFO-FDA

Related Information


Back to Top