Diagnostics

FDA ok’s over-the-counter home test for Covid-19

The FDA authorized an at-home antigen test for Covid-19 developed by Ellume. It does not require a prescription.

Ellume’s at-home antigen test does not require a prescription. Users receive their results in a smartphone app. Photo credit: Ellume

 

The Food and Drug Administration gave an emergency use authorization for the first at-home diagnostic test for Covid-19 that doesn’t require a prescription. Ellume, an Australian diagnostics startup, developed the rapid antigen test, which produces results in 15 to 20 minutes.

FDA Commissioner Stephen Hahn stated the EUA was a “major milestone,” adding that the test could be sold in drug stores, letting people quickly get results. After users swab their nose, they put it into a Bluetooth-connected analyzer, which sends the results to users’ smartphones.

Ellume’s test is intended to identify antigens, or certain proteins from SARS-Cov-2, which can indicate current infection. People who are asymptomatic can still use the test.  In a 200-person clinical study, it was able to identify 95% of active infections and 97% of people who tested negative for the coronavirus. That’s less accurate than some of the PCR tests used at many testing sites, but more accurate than some of the other rapid tests.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a news release.

Ellume said it plans to price the test around $30. The company is ramping up manufacturing at its facility in Brisbane, Australia, and plans to ship more than 20 million tests to the U.S. in the first half of 2021. The company received a $30 million WP-2 grant from the National Institutes of Health to fast-track the development of its Covid-19 tests.

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Last month, the FDA gave the green light to another rapid at-home test developed by Lucira. Patients receive results from the rapid molecular test within 30 minutes, but it is only available by prescription.