FDA Authorizes New COVID-19 Tests

UNITED STATES - NOVEMBER 9 - The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

On Wednesday, the United States Food and Drug Administration (FDA) authorized two tests that could let people rest for COVID-19 in their own homes without a prescription.

The two tests approved this week were Quidel’s QuickVue test and Abbott’s BinaxNOW test. NPR reported, “The only other at-home coronavirus test that has been authorized to be sold without a prescription is made by Ellume and is not yet available in stores.”

The tests approved on Wednesday had already been authorized by the FDA in order to test those who were already exhibiting symptoms of COVID-19 but were used under different names. This new authorization allows these tests to be used to test people who do not have any symptoms when used for serial testing. The FDA, in total, has approved three tests with “serial screen claims” in total.

The FDA explained, back on March 16th, that serial testing “involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC 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 also paved the path for other companies with tests that have already received authorization to be able to apply for authorization for over-the-counter versions.

The FDA released a statement on Wednesday that read:

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.”

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, stated, “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.”

He went on to say, “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.”

A CDC Data Tracker shows a sharp decline in active COVID-19 cases across the united states since January, and we see that the case numbers seem to plateau in the past month.

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