Ellume, an Australian company that makes the first fully at-home COVID-19 diagnostic test to be approved by the FDA, is opening its first U.S. production plant in Maryland this year, The Baltimore Sun reported May 10.
The plant will be in Ballenger Creek, employ 1,500 people and make up to 19 million COVID-19 test kits per month.
"We're thrilled to see vaccination rates going up, but we won't reach herd immunity anytime soon. Our feeling is that we want a product that is easy to use, one test with one result, and accessible to consumers for the long haul," Dan Mallon, Ellume's vice president of business development, told the Sun.
The U.S. Defense Department signed a $231.8 million deal with Ellume in February to onshore the production of its COVID-19 tests. The test costs about $30 and doesn't require a prescription. Users perform a nasal swab and insert the sample into an analyzer, which sends results to a smartphone about 15 minutes later. The FDA authorized the test in December for emergency use after it demonstrated 96 percent accuracy in a U.S. clinical trial.
CVS recently said it would begin selling the Ellume test.
Ellume has committed to providing the U.S. with 8.5 million tests. The company also plans to submit more data to be fully approved by the FDA soon, according to the Sun.
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