Trump Administration Steps Up Coronavirus Testing Under Pressure

(Bloomberg) -- The Trump administration has announced new steps to speed up testing for the coronavirus, after widespread warnings about a bottleneck in diagnosing cases that’s failing to provide a clear snapshot of the pandemic’s U.S. footprint.

The Food and Drug Administration announced it had approved the first rounds of high-volume testing, as well as allowing New York state to authorize labs to expand testing on their own. The Trump administration also appointed an official to take charge of coordinating testing among health agencies.

The moves come after ample warnings this week, including from a top administration health official, that testing has so far been inadequate and that shortage of medical supplies may be looming. The virus’s spread has quickly emerged as a defining test of Donald Trump’s presidency. Trump has begun to pivot from downplaying the virus -- pledging the caseload would fall, only to see it jump sharply -- to pledging more would be done, amid warning signs. Trump announced new travel restrictions this week after a raucous debate among aides.

“Testing will soon happen on a very large scale basis,” Trump tweeted Friday morning. “All Red Tape has been cut, ready to go!”

Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, told U.S. lawmakers Thursday that the lack of widespread testing of Americans thus far “is a failing,” and said the U.S. system wasn’t set up to facilitate rapid distribution of testing for a disease that hasn’t been previously encountered. He spoke as lawmakers, including Republicans, expressed frustration that the U.S. wasn’t able to match the response of nations such as South Korea, which is testing 10,000 a day.

On Friday morning, Fauci told television networks in interviews that he expected testing to ramp up. “Within a week we’re going to start seeing a real acceleration of testing,” Fauci told MSNBC. “I think we are going to see a much different situation than we saw just a few weeks ago.”

Private sector involvement will drive an acceleration of testing, he said, “whereas before it was mostly on the burden of the CDC as a public health organization.”

Roche Holding AG this week won emergency U.S. approval for a highly automated coronavirus test, potentially speeding up by 10-fold the ability to test patients. The FDA granted an “emergency use authorization” to the test, which runs on Roche’s cobas 6800/8800 systems. The tool also is available in Europe and countries that accept its CE marking for medical devices, Roche said.

In other steps announced Friday, the FDA effectively authorized New York state to allow certain labs to test patients after validating their tests and notifying the state health department -- a move designed to help speed national testing. Health and Human Services Secretary Alex Azar also appointed Admiral Brett Giroir, the head of the Public Health Service, to coordinate testing among public health agencies.

“He is ideally situated to help ensure that any American who needs a test for COVID-19 can receive it,” Azar said in a written statement.

U.S. officials were also acknowledging they may run out of ventilators if an outbreak spreads too quickly. The U.S. strategic stockpile of ventilators and other health supplies could be overwhelmed amid a major pandemic of the coronavirus, Fauci said.

But another Trump administration official said it’s too soon to know if the country will run out of ventilators, with more than 12,000 stockpiled now. “The reason why we are focusing so much on mitigation is to avoid that situation” of a shortage, Centers for Medicare and Medicaid Services Administrator Seema Verma told CNN Friday morning.

“We have ventilators in our stockpile, and we are prepared to work with the health-care community to get them the ventilators that they need,” she said. “I think at this point, it’s premature to say we don’t have enough. I don’t think we know that right now.”

Fauci declined to say whether Trump should be tested after coming into contact with a person last week who has since been diagnosed as being infected, saying “advice for that should come from the White House physician.”

The FDA said Friday it is giving flexibility to the New York State Department of Health in authorizing certain laboratories in the state to begin patient testing after validating their tests and notifying the health department.

To contact the reporters on this story: Josh Wingrove in Washington at jwingrove4@bloomberg.net;Caitlin Webber in Washington at cwebber4@bloomberg.net

To contact the editors responsible for this story: Kevin Whitelaw at kwhitelaw@bloomberg.net, Elizabeth Wasserman, Larry Liebert

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