Abbott's $5 Covid-19 Rapid Antigen Test Gets Emergency-Use Status From FDA
August 26 2020 - 8:22PM
Dow Jones News
By Sarah Krouse
The U.S. Food and Drug Administration has granted emergency-use
authorization to Abbott Laboratories for a $5 rapid-response
Covid-19 antigen test that is roughly the size of a credit
card.
The low-cost, rapid-response test could be administered in a
doctor's or school nurse's office and uses technology similar to
home pregnancy tests. It returns results in about 15 minutes.
The emergency approval comes as demand grows for greater access
to Covid-19 diagnostic tools that deliver results in minutes,
rather than days to help quickly contain infections.
Abbott said Wednesday it plans to ship tens of millions of the
newly approved tests in September, with plans to increase
production to 50 million tests in October. If the company is able
to do so, the October total would amount to roughly double the
number of tests performed in the U.S. in July.
Some public-health officials and lab executives say lower-cost
rapid tests that can be produced at scale are an important factor
in the country's ability to return to work and school.
Abbott's new test, called the BinaxNOW COVID-19 Ag Card,
searches for virus proteins and is intended to be used for patients
within seven days of feeling coronavirus symptoms. It involves a
nasal swab administered by a health-care professional such as a
doctor, school nurse or pharmacist. The swab is inserted into the
card-like test.
The new test uses lateral flow technology that is similar to a
home pregnancy test and can be linked to a mobile-phone app that
gives an all-clear code, for instance, to those who test negative
at work or school. The company hasn't yet determined its
distribution strategy, an Abbott spokeswoman said, so it is unclear
where the tests will be sent or when they will become
available.
The new tests are intended to be conducted by medical
professionals and aren't sold directly to consumers for at-home
use.
Other rapid-response tests that have received emergency-use
authorizations from the FDA run in cartridges that are analyzed by
boxlike machines that can sit within doctor's offices or nursing
homes. Those tests generally cost $15 to $50, though coronavirus
diagnostic tests are typically free for people with symptoms or
known contact with an infected individual.
The demand for rapid antigen tests and the machines that run
them outstrips what their manufacturers are able to produce.
Abbott said its data show the new antigen test has demonstrated
sensitivity -- the percent of positive cases a test accurately
detects -- of about 97%. Rapid antigen tests are generally thought
to be less sensitive than lab-based PCR tests.
The company earlier this year began investing in two U.S.
production facilities to produce large numbers of the new tests,
said John Hackett, divisional vice president of applied research
and technology for Abbott's diagnostics unit.
"It's frankly what the country needs right now," said Dr.
Hackett. "The drive behind this from day one has been to get people
back to work, back to school," he added.
The company makes several other types of coronavirus tests
including a rapid molecular test used by the White House that
delivers results in under 15 minutes. The company revised
instructions for use of that rapid test after a preliminary study
by a major medical center found that it frequently gave false
negative results.
Many states raced to secure those tests, with some frustrated
over how long it took to have orders filled. The federal government
has purchased large numbers of rapid-response Covid-19 tests
through the pandemic and typically gets priority distribution.
Write to Sarah Krouse at sarah.krouse@wsj.com
(END) Dow Jones Newswires
August 26, 2020 20:07 ET (00:07 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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