Coronavirus (COVID-19) Update: December 16, 2020

FDA News Release

• For Immediate Release: December 16, 2020

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

• Today, the FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample.
  
  The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.
• Furthermore, yesterday, the agency issued an EUA for the first over-the-counter, at-home, rapid diagnostic test for COVID-19. The Ellume COVID-19 Home Test, authorized for individuals 2 years old and older, with or without symptoms, detects proteins of the SARS-CoV-2 virus from a nasal swab sample. It can be used completely at home without a prescription and requires the use of a compatible smartphone and a downloadable app to provide testing instructions and deliver results in as little as 20 minutes.
• The FDA also posted online background materials for this week’s upcoming Vaccines and Related Biological Products Advisory Committee public meeting. The committee will meet in open session on Thursday, Dec. 17, to discuss Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.
• Testing updates:
  • As of Dec. 16, 303 tests and sample collection devices are authorized by FDA under EUAs; these include 231 molecular tests and sample collection devices, 62 antibody tests, and 10 antigen tests.

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.