FDA streamlines pathway to at-home asymptomatic COVID-19 test approval

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.
By Mallory Hackett
12:54 pm
Woman puts at-home COVID-19 test into sample bag.

(Photo by d3sign/Getty Images)

This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening tests before their effectiveness is studied in asymptomatic individuals.

Test developers seeking this over-the-counter authorization can apply using a template provided by the FDA to share data on who the test is intended for and how well the test works, and provide instructions for its use.

Authorizations are available for developers of tests intended to be used in serial screening programs or for serial at-home use to detect COVID-19 in asymptomatic people. This includes tests conducted in any location, including in a laboratory, at the point-of-care, in a person’s home or in certain nontraditional sites such as offices, sporting venues, airports and schools, according to the FDA.

Although some rapid COVID-19 tests are less accurate in asymptomatic individuals, FDA officials say that when tests are repeated over time, the likelihood of incorrect results will go down.

“The FDA believes that evidence of a test’s strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals,” FDA medical device director Dr. Jeff Shuren and diagnostics director Dr. Tim Stenzel said in a statement.

While the template offers recommendations for information that should be included in applications, the agency stressed it is suggesting, not requiring, this template be used to apply.

Along with the authorization guidance, the FDA issued a fact sheet to help organizations select a test to use in their screening programs. Intended for use among schools, workplaces and communities, the fact sheet offers information on how to distinguish between tests used for diagnosing suspected COVID-19 and those used for screening asymptomatic individuals.

It also notes that testing has a limited value if it’s not combined with other infection-control measures such as quarantining when tests are positive, effective contact tracing and consistent behavioral protocols.


By creating a streamlined pathway to authorization, the FDA is expanding the availability of testing for asymptomatic individuals while bolstering new and existing testing programs, the agency said in its announcement.

Screening testing involves people who don’t have symptoms and who don’t have known or suspected exposure to COVID-19 in order to help make infection-control decisions based on its results.

This type of testing can be used to test employees in a workplace setting, students and staff in schools, or individuals before and after travel. It is a “key component” in stopping the spread of COVID-19, according to the Centers for Disease Control and Prevention.

When screening programs implement serial testing, they can further mitigate the spread of COVID-19 because outbreak prevention and control is increasingly being thought to depend on the frequency of testing and the speed of reporting, the CDC said.

It recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission


The FDA has authorized hundreds of mail-order, in-home, OTC or app-connected COVID-19 tests over the past year. Notably, it gave its first EUA for home testing to Lucira last November, its first OTC in-home diagnostic test EUA to Ellume Health last December and its first at-home OTC molecular test EUA to Cue Health this March.

Since taking office, the Biden Administration has made a number of moves to expand testing.

The Department of Defense, with the Department of Health and Human Services, cut a $231.8 million deal with Ellume in February to deliver 8.5 million tests across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy.

HHS has also made two separate billion-dollar investments in COVID-19 testing in recent weeks. The first sent $650 million to expand testing for K-8 schools and in underserved settings such as homeless shelters and $815 million to increase domestic manufacturing of testing supplies.

The second provides $10 billion to establish COVID-19-screening testing programs in schools and $2.25 billion to improve testing among racial and ethnic minority groups and people living in rural areas.


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