FDA allows use of over-the-counter home test for COVID-19

A home test for COVID-19 will soon be on U.S. store shelves

WASHINGTON — The first home test for COVID-19 that doesn’t require a prescription will soon be on U.S. store shelves.

The agency’s action allows the test to be sold in places like drugstores “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 Hahn, in a statement.

Regulators granted emergency use for a similar test last month, but that one requires a doctor’s prescription.

Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.

A company spokesperson said the test will be priced around $30 and be available at pharmacies and online. The test connects to a digital app to help users interpret the results.

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