FDA authorizes first at-home, over the counter COVID-19 test

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Pretty soon you will be able to take a COVID-19 test in the comfort of your own home.

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On Tuesday, The Food and Drug Administration green lit a at home test which will be available over the counter in the first half of 2021, per The Hill.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said the head of the FDA device center, Jeff Shuren. “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.” 

The test is made by Ellume and users will get results sent to their phone through a “Bluetooth connected analyzer,” after swabbing their nose. As far as pricing, the company said its “intention is to price the test at $30 or less,” and added that “while our initial investments in manufacturing are very large and the initial price may be higher, we are aiming to make this product as accessible as possible.”

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Some experts have been advocating for the rapid at home tests for months.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said  Stephen Hahn, FDA Commissioner. “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.”

The availability of the tests will be limited in the beginning. The company estimates 20 million tests are expected in 2021 and the FDA says about 3 million tests will be available by January.

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