March 8, 2020 By Jaimy Lee
Getty Images
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.”
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.
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.”
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.
He also said that 1.1 million tests manufactured by Integrated DNA Technologies, a Skokie, Ill.,-based company that was acquired by Danaher Corp. DHR, -0.69% 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 LH, -3.91% and Quest Diagnostics Inc. DGX, -3.16%, 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 SPX, -1.70% is down 8% year-to-date.
Separately, a number of commercial diagnostics company have said they will develop COVID-19 tests, including Laboratory Corporation of America LH, -3.91% and Quest Diagnostics Inc. DGX, -3.16%, 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 SPX, -1.70% is down 8% year-to-date.
The US government has completed fewer than 6,000 coronavirus tests as more states report new cases and deaths
Business Insider•March 7, 2020
Coronavirus test kits in Krasnodar, Russia, on February 4, 2020.
AP Photo
The US Centers for Disease Control and Prevention has tested fewer than 6,000 potential coronavirus cases so far.
The figure came from FDA Commissioner Stephen Hahn on Saturday, who last week promised there would be 1 million test kits available by the end of the week.
The US was unable to meet that goal, though Vice President Mike Pence said Thursday the nation will produce some 1.2 million kits by next week.
The US has struggled with its coronavirus response, in part due to an issue with CDC-issued test kits that ended up requiring states to send the CDC all cases for testing.
Officials expect the number of tests completed to rise substantially over the next week.
The United States government has conducted 5,861 tests for the novel coronavirus as of Friday at 6 p.m., US Food and Drug Administration Commissioner Stephen Hahn said on Saturday at an off-camera press briefing, CNN reported.
The report comes amid a rise in US cases as the virus continues to spread across the country. New York Gov. Andrew Cuomo declared a state of emergency in his state after announcing 21 new cases on Saturday, joining a handful of other states that have declared public emergencies as a result of people testing positive for COVID-19.
There have been at least 19 deaths in the US from the virus that has killed nearly 3,500 globally so far. Most fatalities have occurred in China.
As CNN reported, the number does not mean 5,861 people have been tested for the virus, as those who are tested for typically have two swabs taken and tested: one nose swab and one throat swab. The number also does not account for tests at private labs.
Saturday marked the first time the US government released official numbers on coronavirus tests.
The Centers for Disease Control and Prevention, which conducts coronavirus testing, has faced backlash over its handling of US cases. While other countries affected by outbreaks of the virus, which is believed to have originated in China at the end of last year, have tested millions of patients for potential coronavirus, the US has tested just thousands, according to a report from MIT Technology Review.
Part of the issue, the report said, is faulty COVID-19 testing kits issued to states by the CDC in early February. The kits were found to have "faulty negative controls," meaning the results of some test kits were inaccurate, and states had to continue sending test samples to the CDC for testing.
FDA policy prohibited states and private entities from developing their own test kits, meaning they only had access to the faulty FDA kits. The agency lifted that regulation on February 29, allowing states and commercial labs to create their own coronavirus testing kits.
As Business Insider previously reported, Vice President Mike Pence — the Trump-appointed head of the US coronavirus task force — admitted that the country was not able to meet up with the demand for the test kits.
The FDA commissioner had promised March 2 that the US would have 1 million test kits available by the end of the week, though Pence said the country failed to meet such a promise.
"We don't have enough tests today to meet what we anticipate will be the demand going forward," the vice president said Thursday, telling the BBC that the new goal would be met next week and had been increased to 1.2 million testing kits.
The CDC on March 4 broadened its criteria for testing, allowing more individuals exhibiting symptoms of the disease to be tested.
Read more:
New York Gov. Andrew Cuomo declares a state of emergency and confirms 76 cases of coronavirus in the state
The number of coronavirus cases outside China could jump tenfold every 19 days without 'strong intervention,' a study says
AP Photo
The US Centers for Disease Control and Prevention has tested fewer than 6,000 potential coronavirus cases so far.
The figure came from FDA Commissioner Stephen Hahn on Saturday, who last week promised there would be 1 million test kits available by the end of the week.
The US was unable to meet that goal, though Vice President Mike Pence said Thursday the nation will produce some 1.2 million kits by next week.
The US has struggled with its coronavirus response, in part due to an issue with CDC-issued test kits that ended up requiring states to send the CDC all cases for testing.
Officials expect the number of tests completed to rise substantially over the next week.
The United States government has conducted 5,861 tests for the novel coronavirus as of Friday at 6 p.m., US Food and Drug Administration Commissioner Stephen Hahn said on Saturday at an off-camera press briefing, CNN reported.
The report comes amid a rise in US cases as the virus continues to spread across the country. New York Gov. Andrew Cuomo declared a state of emergency in his state after announcing 21 new cases on Saturday, joining a handful of other states that have declared public emergencies as a result of people testing positive for COVID-19.
There have been at least 19 deaths in the US from the virus that has killed nearly 3,500 globally so far. Most fatalities have occurred in China.
As CNN reported, the number does not mean 5,861 people have been tested for the virus, as those who are tested for typically have two swabs taken and tested: one nose swab and one throat swab. The number also does not account for tests at private labs.
Saturday marked the first time the US government released official numbers on coronavirus tests.
The Centers for Disease Control and Prevention, which conducts coronavirus testing, has faced backlash over its handling of US cases. While other countries affected by outbreaks of the virus, which is believed to have originated in China at the end of last year, have tested millions of patients for potential coronavirus, the US has tested just thousands, according to a report from MIT Technology Review.
Part of the issue, the report said, is faulty COVID-19 testing kits issued to states by the CDC in early February. The kits were found to have "faulty negative controls," meaning the results of some test kits were inaccurate, and states had to continue sending test samples to the CDC for testing.
FDA policy prohibited states and private entities from developing their own test kits, meaning they only had access to the faulty FDA kits. The agency lifted that regulation on February 29, allowing states and commercial labs to create their own coronavirus testing kits.
As Business Insider previously reported, Vice President Mike Pence — the Trump-appointed head of the US coronavirus task force — admitted that the country was not able to meet up with the demand for the test kits.
The FDA commissioner had promised March 2 that the US would have 1 million test kits available by the end of the week, though Pence said the country failed to meet such a promise.
"We don't have enough tests today to meet what we anticipate will be the demand going forward," the vice president said Thursday, telling the BBC that the new goal would be met next week and had been increased to 1.2 million testing kits.
The CDC on March 4 broadened its criteria for testing, allowing more individuals exhibiting symptoms of the disease to be tested.
Read more:
New York Gov. Andrew Cuomo declares a state of emergency and confirms 76 cases of coronavirus in the state
The number of coronavirus cases outside China could jump tenfold every 19 days without 'strong intervention,' a study says
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