FDA takes action to advance OTC and other screening test development

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.

In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription.

The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These authorizations follow the FDA's recent actions to advance OTC and other screening test development.

Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country's pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19. With the FDA's authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As we've said all along, if it's a good test, we'll authorize it."

Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration

"The FDA has taken many steps to support test development throughout the pandemic, including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims."

In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week:

• Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
• Abbott BinaxNOW (multiple configurations)
  • Abbott BinaxNOW COVID-19 Antigen Self Test - authorized for OTC at-home serial screening
  • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor
  • Abbott BinaxNOW COVID-19 Ag 2 Card - authorized for POC serial screening without a prescription
• BD Veritor System for Rapid Detection of SARS-CoV-2 - authorized for POC serial screening with a prescription

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

These authorizations follow the agency's multiple steps to streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish 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.