Over-the-counter COVID-19 home test approved by FDA
WASHINGTON (AP) - 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.
RELATED: FDA says preliminary analysis confirms effectiveness, safety of Moderna COVID-19 vaccine
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.
A employee checks another employees temperature before entering a store on November 27, 2020 in Louisville, Kentucky. (Photo by Jon Cherry/Getty Images)
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.