“Under President Trump’s leadership, the United States leads the world in testing,” White House communications director Alyssa Farah said in a statement to CNBC. “This is a major development that will help our country stay open, get Americans back to work and kids back to school. The Trump administration is proud to partner with Abbott Labs to make this purchase possible to help the American people. ”
The Food and Drug Administration granted Abbott emergency use authorization on Wednesday for its new coronavirus antigen test, which is the first Covid-19 test it says costs around $ 5 and provides results in minutes on a test card without lab equipment, similar to a pregnancy test.
Abbott shares jumped more than 9% in intraday trading on Thursday.
Abbott said in a statement after receiving clearance from the FDA that it would “ship tens of millions of tests in September, bringing production to 50 million tests per month in October.”
Representatives for Abbott Labs did not immediately return CNBC’s request for comment. Representatives of the Department of Health and Human Services declined to comment.
The test, called BinaxNOW, is an antigen test, which is a bit more likely to misdiagnose a person as negative when they are in fact infected with Covid-19 than molecular tests. Although molecular testing is the most accurate on the market, it relies on technical laboratory equipment, trained personnel, and a tight supply chain, making it difficult to expand molecular testing on a massive scale.
“Due to the potential for decreased sensitivity compared to molecular testing, negative results from an antigen test may need to be confirmed by molecular testing before making treatment decisions,” the FDA said in its clearance. of the BinaxNOW test. “Negative results of an antigen test should be viewed in the context of clinical findings, patient history and epidemiological information. ”
The test is currently only authorized for use in patients suspected of having Covid-19 and “within seven days of onset of symptoms,” says the FDA, which means it is not authorized to test asymptomatic or presymptomatic people.
“This test could be used in healthcare settings, such as a doctor’s office, emergency room, or certain schools,” says the FDA. “Given the simple nature of this test, it is likely that these tests could be widely available. ”
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