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FDA News Release

Coronavirus (COVID-19) Update: April 2, 2021

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:

  • Following recent FDA actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. On March 31, the FDA authorized several COVID-19 tests for over-the-counter (OTC) use without a prescription when used for serial screening (testing asymptomatic individuals multiple times on a routine basis), such as testing twice a week in schools or other settings. The FDA also authorized serial screening tests for use in a point-of-care (POC) setting, such as a doctor’s office. These authorizations follow the FDA’s recent actions to advance OTC and other screening test development. These tests:
    • Can be used to test people with or without COVID-19 symptoms.
    • Are antigen tests that detect proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample.
    • Give results in 10-30 minutes without needing to send a sample to a laboratory for analysis.
  • This week, the FDA posted a new web page SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests for clinical laboratory staff and health care providers about the impact of viral mutations on COVID-19 molecular, antigen, and serology tests. This web page builds on the letter the FDA issued January 8, 2021, alerting clinical laboratory staff and health care providers to the potential for false negative results due to the impact of viral mutations on molecular SARS-CoV-2 tests. The web page includes specific molecular tests impacted by viral mutations and recommendations for those tests, including, new information on Cepheid Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, and Xpert Omni SARS-CoV-2 tests. The FDA will update this page as significant new information about viral mutations and impact on COVID-19 tests becomes available. The FDA will announce any updates by email to CDRH In Vitro Diagnostics email list subscribers and in COVID-19 Update press releases.
  • Today, the FDA posted translations of the Consumer Update: Learn More about COVID-19 Vaccines From the FDA in five additional languages: Chinese, Korean, Spanish, Tagalog, and Vietnamese.
  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Natural Adventure, LLC for selling unapproved products with fraudulent COVID-19 claims. The company sells “Purity Sanitizer with 70% Alcohol” and “Purity Essential Oil Blend” and misleadingly represents that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Natural Adventure, LLC take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • As of today, 354 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 258 molecular tests and sample collection devices, 74 antibody and other immune response tests, and 22 antigen tests. There are 43 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, four over-the-counter (OTC) at-home antigen test, and one OTC molecular test.

      The FDA has authorized six antigen tests for serial screening programs.

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.

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Lindsey O’Keefe

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