FDA authorizes 1st over-the-counter, at-home COVID-19 test for emergency use

The Food and Drug Administration on Tuesday issued an emergency use authorization for the first over-the-counter, fully at-home COVID-19 test for emergency use. Previously, the agency authorized the first prescription COVID-19 test for home use, and the first non-prescription test system that allows people to take their own samples before sending it to a lab for analysis. The latest news appears to combine the best of the worlds.

The Ellume COVID-19 Home Test will likely be sold at pharmacies, and it won't require a prescription. FDA Commissioner Stephen Hahn said patients can buy the rapid antigen kit, take it home, conduct their own nasal swab, and get their results "in as little as 20 minutes." As is the case with most tests, the FDA cautions there is a risk of false positive and negative results.

Ellume says its intention is for the test to cost $30 or less and while production has just started, the company expects to send out initial shipments the first week of January.

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There is hope that at-home testing will not only expand Americans' access to coronavirus testing, but also reduce the burden on laboratories and test supplies, Hahn said. Read more the FDA's full announcement here.