The FDA expands coronavirus tests after CDC defects undermine the fight against disease

The effort of the U.S. Centers for Disease Control and Prevention to protect Americans from the new coronavirus has been hampered by a poor disease test and limited access to reliable analysis, resulting in significant delays in determining which people have the virus, according to officials and experts.

But the Food and Drug Administration announced Saturday that labs and hospitals across the nation will now be able to conduct the tests and will not have to wait for the results of the CDC.

“We believe this policy strikes the right balance during this public health emergency,” said FDA commissioner Dr. Stephen Hahn in a note. “We will continue to help ensure solid science before clinical trials and follow-up with independent critical review by the FDA, rapidly expanding testing capabilities in the United States.”

The anomalies in the CDC test system contrasted the wide-ranging surveillance tests to track the disease and eliminate concerns for healthy people by simply fighting a common cold.

China currently has the ability to test 1.6 million people per week for COVID-19 and South Korea has already tested around 65,000 people, according to Science Magazine. As of Friday, fewer than 500 people in the United States had been tested, according to the CDC.

The CDC has ignored the World Health Organization’s testing guidelines to design its own test. But several test kits sent to states have had inconclusive results, so most states have had to rely on CDC analysis, creating a backlog, according to ProPublica.

“We are weeks behind because we had this problem,” Scott Becker, chief executive officer of the Association of Public Health Laboratories, told ProPublica. “Usually we are in the foreground, in the center and ready.”

Until recently, the CDC has also limited the use of kits to suspected cases of COVID-19 among people who had traveled to China within two weeks of developing symptoms or who had been in close contact with someone with the disease.

A Washington County health director, where the nation’s first coronavirus fatality occurred, complained on Saturday of the delay in critically identifying people with the disease caused by blocking tests and strict CDC criteria before they could even conduct a test.

“If we had had the chance to run the tests earlier, I’m sure we would have identified the patients earlier,” said Jeff Duchin. Early detection is critical for people to be able to start treatment and be isolated before passing on the virus to someone else.

Washington state officials announced two new cases of illness on Friday, the death of a coronavirus man on Saturday and an apparent outbreak of COVID-19 in a nursing home in the Seattle area where two people have already given positive results and dozens of others have symptoms.

This week New York and the state got permission from CDC and FDA to develop their tests in an attempt to simplify the process. CDC said that the tests it provides should offer reliable reading on COVID-19 in many laboratories, although other elements of the test may not work. But New York officials aren’t convinced they can rely on the results of the CDC tests.

“Tests for coronavirus are not yet available in New York City,” said Department of Health spokeswoman Stephanie Buhle in an email to ProPublica. “The kits that have been sent to us have shown performance issues and cannot be relied on to provide an accurate result.”

Dozens of state, university and private company labs have already applied for emergency approval for their tests. Once they have presented evidence of how these tests work, they will be able to use them immediately, according to the New York Times.

President Donald Trump at a press conference on Saturday announced measures to block visitors to the United States from countries hit hard by the virus and encouraged Americans not to travel to those countries. He did not address the test problem.


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