FDA Expands Coronavirus Testing After CDC Glitches Undermine Fight Against Disease

Testing logjam is keeping vital information from patients and health officials.

The effort by the U.S. Centers for Disease Control and Prevention to protect Americans from the new coronavirus has been hamstrung by a flawed test for the disease and limited access to a reliable analysis, resulting in significant delays to determine 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 test and won’t have to wait for results from the CDC.

“We believe this policy strikes the right balance during this public health emergency,” FDA Commissioner Dr. Stephen Hahn said in a statement. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S.”

Glitches in the CDC testing system have thwarted wide-ranging surveillance testing to track the disease and eliminate concerns about healthy people simply battling a common cold.

China currently has the capability to test 1.6 million people a week for COVID-19, and South Korea has already tested some 65,000 people, reported Science Magazine. As of Friday, fewer than 500 people in the U.S. had been tested, according to the CDC.

The CDC ignored World Health Organization testing guidelines to devise its own test. But several testing kits sent to states had inconclusive results, so most states had to rely on CDC analysis, creating a backlog, ProPublica reported.

“We’re weeks behind because we had this problem,” Scott Becker, chief executive officer of the Association of Public Health Laboratories, told ProPublica. “We’re usually up-front and center and ready.”

The CDC until recently also restricted use of the 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 illness.

A county health director in Washington, where the nation’s first coronavirus fatality occurred, complained Saturday about the delay in critical identification of people with the disease caused by the testing holdup and the CDC’s strict criteria before a test could even be conducted.

“If we had the ability to test earlier, I’m sure we would have identified patients earlier,” said Jeff Duchin. Early detection is critical so that people can begin treatment and be isolated before passing on the virus to someone else.

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

New York City and the state obtained permission this week from the CDC and FDA to develop their own tests in an effort to streamline the process. CDC has said tests it provides should offer a reliable read on COVID-19 in many labs, even though other elements of the test may not work. But New York officials aren’t convinced they can rely on the CDC test results.

“Testing for coronavirus is not available yet in New York City,” Department of Health spokeswoman Stephanie Buhle said in an email to ProPublica. “The kits that were sent to us have demonstrated performance issues and cannot be relied upon to provide an accurate result.”

Dozens of state, university and private company labs have already applied for emergency approval for their own tests. Once they have submitted evidence that those tests work, they will be able to use them immediately, The New York Times reported.

President Donald Trump in a press conference Saturday announced measures to block visitors to the U.S. from countries hit hard by the virus, and encouraged Americans not to travel to those nations. He did not address the testing issue.

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