The United States on Tuesday authorized its first rapid at-home test for COVID-19, AFP reports.
The test, made by California-based Ellume, is available over-the-counter and produces a result in around 20 minutes.
It will sell for around $30 and the company plans to roll out three million units in January 2021, and millions more in subsequent months.
Stephen Hahn, commissioner of the Food and Drug Administration (FDA), said the emergency use authorization represented a "major milestone."
"We are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes," he said.
The test is an "antigen" test, meaning it works by detecting a surface molecule of the coronavirus, unlike the more common PCR tests that look for the virus' genetic material.
It uses a nasal swab that doesn't go as far back as the nasopharyngeal swabs used in clinical settings, and is therefore more comfortable to self-administer.
The FDA said the Elliume test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms.
In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.
Ellume developed the test with $30 million in government funding from the National Institutes of Health.