U.S. approves Abbott coronavirus test; company set to ship 150,000

[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 global pandemic.

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 week.

"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 telephone interview.

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>.

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 Arun Koyyur)

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