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March 9, 2020, 7:33 a.m. EDT

FDA commissioner: CDC coronavirus tests have been used for 1,583 patients

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By Jaimy Lee


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The Food and Drug Administration (FDA) said Saturday that the government has shipped enough kits to test approximately 75,000 people for COVID-19, the novel coronavirus that has sickened more than 400 people and killed 19 in the U.S.

COVID-19, which was first detected in December in Wuhan, China, has since spread to more than 90 countries and has led to infections in more than 107,000 people worldwide and at least 3,600 deaths, according to the Johns Hopkins Whiting School of Engineering’s Centers for Systems Science and Engineering.

In remarks made on Saturday at a White House press briefing, FDA commissioner Stephen Hahn acknowledged some of the problems with the test developed by the Centers for Disease Control and Prevention (CDC).

“There were manufacturing problems with the CDC test,” Hahn said. “While those issues have been resolved, at the time, this created complications for expanding access for public health laboratories and other developers who might use the CDC test as the basis for development of their own test.”

Read: FDA to now allow more labs to immediately begin testing for coronavirus

The administration has been criticized for the botched rollout of the tests. There have been a number of problems with the tests, including an issue with the third component of the test kit, which required public health laboratories to send the test to the CDC in Atlanta for final confirmation, as well as questions about the availability of the test, particularly in states with growing clusters of infections like Washington state.

“I believe the CDC was caught flat-footed,” New York state Gov. Andrew Cuomo said Saturday. “I believe they’re slow in their response, and I believe they’re slowing down the state.”

Hahn said that the CDC kits have been used in the U.S. to test 1,583 patients, which is three times as many people who had been tested by Feb. 29 , but still far below the number of people who have been tested in countries like South Korea, which has tested more than 180,000 people.

See also: Biogen orders employees to work from home after employees at Boston meeting test positive for coronavirus

He also said that 1.1 million tests manufactured by Integrated DNA Technologies, a Skokie, Ill.,-based company that was acquired by Danaher Corp. /zigman2/quotes/210555154/composite DHR -1.13%  in 2018, had been shipped to nonpublic health labs on Friday. “IDT and other manufacturers believe they can scale up production so that by the end of next week, an additional 4 million tests could be shipped,” Hahn said.

Separately, a number of commercial diagnostics company have said they will develop COVID-19 tests, including Laboratory Corporation of America /zigman2/quotes/203174601/composite LH -0.92%  and Quest Diagnostics Inc. /zigman2/quotes/201001842/composite DGX -0.73% , which both announced plans on Thursday to do so. LabCorp’s stock is up 6% year-to-date, while shares of Quest have gained 4%. The S&P 500 /zigman2/quotes/210599714/realtime SPX -0.39%  is down 8% year-to-date.

/zigman2/quotes/210555154/composite
US : U.S.: NYSE
$ 246.37
-2.82 -1.13%
Volume: 2.35M
May 16, 2022 4:03p
P/E Ratio
28.53
Dividend Yield
0.41%
Market Cap
$181.18 billion
Rev. per Employee
$378,537
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/zigman2/quotes/203174601/composite
US : U.S.: NYSE
$ 242.38
-2.24 -0.92%
Volume: 626,954
May 16, 2022 4:00p
P/E Ratio
11.13
Dividend Yield
1.19%
Market Cap
$22.79 billion
Rev. per Employee
$210,053
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/zigman2/quotes/201001842/composite
US : U.S.: NYSE
$ 135.39
-1.00 -0.73%
Volume: 963,897
May 16, 2022 4:03p
P/E Ratio
9.02
Dividend Yield
1.95%
Market Cap
$16.01 billion
Rev. per Employee
$217,939
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/zigman2/quotes/210599714/realtime
US : S&P US
4,008.01
-15.88 -0.39%
Volume: 2.21B
May 16, 2022 5:14p
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Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

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