approves Abbott coronavirus test; company set to ship
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[March 19, 2020]
By Julie Steenhuysen and Carl O'Donnell
(Reuters) - The U.S. Food and Drug
Administration on Wednesday granted Abbott Laboratories <ABT.N> approval
to sell a test for the new coronavirus, as more companies begin
producing much needed diagnostics for the pathogen that has set off a
The tests will help meet a major U.S. shortfall of diagnostic
capabilities that has severely limited the nation's ability to track
the spread of the outbreak.
The rise in U.S. cases of COVID-19, a highly contagious and
sometimes fatal respiratory illness, has concerned health officials
and spurred calls from lawmakers for action to expand testing
capacity to slow its spread. Governors around the country have been
begging for more test kits.
Abbott said it plans to immediately distribute around 150,000 tests
to customers in the United States and will continue to ramp up
production to hit a goal of providing up to 1 million tests per
"This is an example of what people can achieve when they come
together in a moment of great need," John Hackett, divisional vice
president of applied research and technology at Abbott, said in a
The tests will be conducted on Abbott's m2000 platform, which is
currently installed in 175 labs across the country.
"The majority of the systems are in hospital labs or academic center
labs," Hackett said. "These are the places where you need them."
The FDA has been rushing to approve tests for the coronavirus on an
emergency basis and has approved those made by Roche Holding AG <ROG.S>
and Thermo Fisher Scientific Inc <TMO.N>.
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Vice President Mike Pence, who is leading the White House's coronavirus task
force, said on March 4 that roughly 1.5 million tests would be available by the
end of that week, while President Donald Trump said the same week that "anyone
who wants a test, gets a test."
Those assurances proved not to be the case and the United States lags far behind
most other industrialized nations in coronavirus testing that public health
officials deem critically important.
The U.S. Centers for Disease Control and Prevention reported that just over
30,000 coronavirus tests have been conducted by federal, state and local
laboratories so far.
With the expansion of testing comes a surge in confirmed cases of COVID-19. More
than 200,000 cases have been reported worldwide and over 7,000 in the United
States with 118 deaths, according to a tally kept by John's Hopkins University.
(Reporting by Julie Steenhuysen and Carl O'Donnell; Editing by Bill Berkrot and
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