The Food and Drug Administration will allow some developers of Covid-19 tests to market their products for regular at-home use without first studying how well the tests perform in people without symptoms.
The agency’s announcement Tuesday is aimed at making it easier to screen Americans returning to school and work, senior FDA regulators said.
“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” FDA medical device director Jeff Shuren and diagnostics director Tim Stenzel said in a statement.
Some rapid Covid-19 tests are less accurate in people without symptoms than in those with symptoms. But the FDA’s new policy takes into account that repeated testing over time, for screening purposes, can improve the overall accuracy of results.
Companies can apply for permission to market an over-the-counter test for use at home or at point-of-care if there is evidence the test performs well in people with symptoms of Covid-19 and if repeated testing can help mitigate false results. The agency is issuing a new template for test developers seeking an emergency use authorization for a screening test that is used for repeated testing.
“It is important to note that testing, even serial testing, is of limited value if it is not combined with appropriate mitigations for individuals who test positive (such as quarantine), good contact tracing, and effective behavioral protocols (such as mask wearing, hand washing and social distancing), even for individuals who test negative,” an FDA fact sheet about the new policy states.
Background: Some public health groups, including the Rockefeller Foundation, and public health experts such as Harvard University’s Michael Mina, have argued for months that increasing the availability of Covid-19 tests could help bring the Covid-19 pandemic under control.
What’s next: FDA also released a fact sheet that aims to help groups setting up screening testing programs. The Biden administration is working to stand up four coordinating centers across the country to increase testing in K-8 schools and underserved settings.
“The fact sheet will help schools, workplaces, communities and other locations as they are selecting a test for screening and help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals,” Shuren and Stenzel said.
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