The Biden administration has made a $231.8 million deal with an Australian company to boost availability of the first at-home rapid test for the coronavirus which causes COVID-19 that is available without a prescription. The test, made by Ellume, can send results to a smartphone within 15 minutes of receiving a sample.
The Food and Drug Administration gave emergency authorization to Ellume’s rapid test in December, after it showed 96% accuracy in a U.S. clinical study. Those trials included both adults and children of ages 2 years and older.
The company received $30 million last year from the U.S. National Institutes of Health Rapid Acceleration of Diagnostics initiative to support clinical testing and manufacture of the test.
As part of the new contract, Ellume has committed to providing 8.5 million tests to the federal government, said Andy Slavitt, senior advisor to the White House COVID-19 Response Team.
Ellume says it will build its first U.S.-based factory to make the tests, ramping up toward producing 19 million kits each month later this year.
The test uses a relatively short nasal swab to collect a sample. The sample is put into a digital analyzer linked to a smartphone app. In December, the company told NPR the test would be available for about $30.