The Food and Drug Administration (FDA) on Tuesday granted emergency authorization to the first over the counter, fully at-home test for COVID-19.
The move is a significant step forward in expanding the reach of rapid, at-home coronavirus tests, something experts have been advocating for months. Still, there will be limitations on supply and cost could be a barrier to widespread, repeated use.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said FDA Commissioner Stephen Hahn. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”
The test is made by a company called Ellume. People swab their nose and then use a “Bluetooth connected analyzer” that sends the results to their smartphone, the company said.
The company said it plans to have 20 million tests available in the United States in the first half of 2021. The FDA said 3 million tests would be produced in January.
That is a significant number, but far less than the hundreds of millions that would be needed for the goal some experts have advocated of allowing every household to have access to a cheap $1 paper strip test they could be tested multiple times a week, helping people to return to work and school. Some experts have pushed the FDA to move faster in authorizing new tests, saying it has been too concerned with making sure they fully live up to the highest accuracy standards.
A spokesperson for Ellume said the company’s “intention is to price the test at $30 or less,” adding that “while our initial investments in manufacturing are very large and the initial price may be higher, we are aiming to make this product as accessible as possible.”
The company said it received $30 million from a National Institutes of Health program to spur test development, which helped speed up development.
The test correctly identified 96 percent of positives and 100 percent of negatives in people with symptoms, the FDA said. In people without symptoms, that was 91 percent and 96 percent.
The FDA said people should treat positive results as presumptively true and isolate, but also confirm the result with another test. People with negative results should follow up with their doctor if they still have symptoms, the FDA said.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeff Shuren, head of the FDA device center. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
Shuren said the FDA hopes to keep working to get new rapid tests on the market. “Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” he said.