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

Regulators granted use for a similar test last month, but it requires a doctor's prescription.

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

U.S. officials Tuesday authorized the rapid coronavirus test which can be done entirely at home. The announcement by the Food and Drug Administration represents another important — though incremental — step in U.S. efforts to expand testing options.

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.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

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