FDA Authorizes OTC and POC COVID-19 Tests

FDA has attached a rocket to a plan to get more tests for screening asymptomatic individuals. The agency has authorized several COVID-19-related tests for over-the-counter-use and some for point-of-care use.

“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 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,” said Jeff Shuren, MD, J.D., director of FDA’s Center for Devices and Radiological Health. “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.”

Here is a breakdown of the test and claims.

FDA said the authorizations follow its recent actions to advance OTC and other screening test development. In mid-March, FDA granted marketing authorization to BioFire Diagnostic’s Respiratory Panel 2.1.  – making it the first company to receive de novo designation.

The granting of the de novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens.