First OTC, at-home COVID-19 test garners EUA

Regulatory NewsRegulatory News
| 15 December 2020 | By Kari Oakes 

The US Food and Drug Administration has authorized the first at-home antigen test for COVID-19 that will be available for over the counter purchase. The rapid lateral flow test is authorized for use with a nasal swab from individuals at least 2 years old, and it may be used in asymptomatic individuals.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, MD in a press statement announcing the new test.
In the statement, FDA noted that emergency use authorizations (EUAs) have also been issued for a prescription test for home use, and for a non-prescription system where a laboratory processes a self-collected sample. (RELATED: Rapid standalone COVID antigen test nabs EUA, Regulatory Focus 27 August 2020)
More than 25 tests are now available for home sample collection, though all but the newly authorized Ellume home test require that the test be sent to a lab for testing.
To use the Ellume test, users must also install a software app on a smartphone to help with test performance and interpretation. The only information required by the app are zip code and date of birth; name and email may optionally be entered. According to FDA, “results as appropriate” are reported to public health authorities.
Australia-based Ellume Limited expected to produce more than 3 million tests by January 2021.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” said Hahn.
EUA letter of authorization


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Tags: coronavirus, FDA, US

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