Ellume’s at-home test costs about $30 and does not require a prescription. Users perform a nasal swab and insert the sample into an analyzer, with results sent to a smartphone about 15 minutes later.
The FDA approved Ellume’s test Dec. 15 after it demonstrated 96 percent accuracy in a U.S. clinical study. The agency has approved three at-home COVID-19 tests, but Ellume’s is the only one that doesn’t require a prescription. Currently, none are widely available.
The deal will help fund construction of Ellume’s first manufacturing facility in the U.S., with the goal of producing 640,000 tests per day by December. Ellume has committed to providing the U.S. with 8.5 million tests.
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