U.S. Cuts $231 Million Deal To Provide 15-Minute COVID-19 At-Home Tests
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.
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.
In a press release, the company said its contract, with the U.S. Defense Department, will help fund construction of Ellume's first manufacturing plant in the U.S. Once completed, it will produce more than 500,000 tests per day, according to the company.
In October the company received a $30 million grant 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.
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.
The Biden administration is trying to bolster testing efforts in the U.S., the worst-hit country in the world, as new variants of the SARS-CoV-2 virus threaten to make it even more difficult to bring under control.
The U.S. average daily testing rate now stands at 550 per 100,000 people, according to a seven-day moving average computed by Johns Hopkins University. That rate compares well to a number of smaller countries, but it sharply lags the U.K. — another nation hit hard by the pandemic — which has been testing an average of 986 people per 100,000.
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