For immediate release:

Following recent actions by the U.S. Food and Drug Administration to support test development, the FDA took swift action this week to get more tests for asymptomatic individuals on the market. Today, the agency has cleared several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to tests permitted for over-the-counter use, one serial drug test has been cleared for point-of-care (POC) use without a prescription, and one additional drug test has been cleared for use with a prescription. . The addition of OTC and POC tests for screening will give schools, workplaces, communities and others several options for accurate and reliable serial screening tests. These approvals follow recent actions by the FDA to advance the development of OTC and other screening tests.

“Screening tests, especially with the over-the-counter tests licensed today, are an important part of the country’s response to the pandemic – many schools, workplaces, communities and other entities are implementing programs to test to quickly find COVID-19. With the approval of several tests by the FDA, the public can be assured that these tests meet our scientific standards for emergency use authorization. As we’ve always said, if it’s a good test, we’ll allow it, ”said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA has taken many steps to support test development throughout the pandemic, including quickly clearing testing, providing ample opportunities for test developers to work with us to bring their tests to market, s ‘they are proven to be accurate and reliable, and by issuing enforcement policies for COVID-19 testing. As the pandemic progressed, we worked with test developers who wanted to add testing claims. “

In total, the FDA has cleared three tests with serial screening claims (testing asymptomatic individuals multiple times in a systematic way). Specific tests authorized this week:

  • Quidel QuickVue At-Home OTC COVID-19 Test – Cleared for Serial OTC Home Testing
  • Abbott BinaxNOW (multiple configurations)
    • Abbott BinaxNOW COVID-19 Antigen Self-Test – Cleared for Over-the-Counter Serial Home Screening
    • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – cleared for serial OTC home screening with a telehealth supervisor
    • Abbott BinaxNOW COVID-19 Ag 2 Card – Authorized for Non-prescription POC Serial Testing
  • BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for serial POC screening with prescription

These tests had previously been authorized by the agency (some under different names) to test people with symptoms of COVID-19, but this week’s actions allow testing of asymptomatic individuals when used for testing. serial.

These clearances follow the agency’s multiple steps to streamline the process for test developers interested in clearing screening with serial testing to increase consumer access to the tests, as well as the information the FDA has released. to help schools, workplaces, communities and others establish screening programs. .

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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