Resource: FDA Continues to Advance Over-the Counter and Other Screening Test Development
Source: U.S. Food and Drug Administration
Synopsis: 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.
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:
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Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
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Abbott BinaxNOW (multiple configurations)
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Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
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Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor
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Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
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BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription
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Comment: 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 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.
