By Peter Sullivan - 12/15/20 12:28 PM EST
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.”
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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.
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“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.”
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