One Million US Coronavirus Tests to Be Available by End of Week: FDA Official

The headquarters of the U.S. Food and Drug Administration is seen in Silver Spring, Maryland, on Nov. 4, 2009. Jason Reed/AP-File

U.S. laboratories should have the materials capable of performing about a million coronavirus tests by the end of the week, U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn claimed, as cases across the nation rose to more than 100 and health officials warned of a surge in numbers.

Hahn said at a Senate committee hearing that by Friday, manufacturers should be able to supply around 2,500 kits to laboratories across the United States. He explained that each kit could allow labs to perform up to 500 tests.

The kits are reportedly being produced by an outside manufacturer, Integrated DNA Technologies, and distributed to public laboratories and “a variety of academic, health care, and commercial labs around the country,” a spokeswoman for the Department of Health and Human Services told The New York Times Tuesday.

“With this new policy we’ve heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests this week, next week, and throughout the month,” Hahn said. “The estimates that we’re getting from industry right now, by the end of this week close to one million tests will be able to be performed.”

The announcement came as Hahn—who recently joined the White House coronavirus task force—said that the FDA has introduced a new policy which would allow specific laboratories to develop and use their own validated COVID-19 screening tests before receiving authorization from the agency, in a bid to accelerate testing capacity in the United States.

Federally certified laboratories will be able to develop and use their own molecular diagnostics tests for the virus without waiting for an emergency use authorization to be issued by the FDA, the agency explained in a release.

Although the labs’ tests will still need to go to the agency for approval, the FDA will provide a grace period of 15 business days during which the labs can use the tests to screen patients while submissions are gathered.

“We believe this policy strikes the right balance during this public health emergency,” 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.”

“This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

The CDC previously advised only testing individuals who either had a history of travel to affected countries or had come into contact with a confirmed COVID-19 case. Meanwhile, testing kits distributed to state and local labs, which were developed by the CDC, had faulty components and produced inconclusive results.

Only seven state labs had the ability to test for the coronavirus locally as of Feb. 26, while the CDC worked on manufacturing new kits that produce more reliable results.

Meanwhile, Eric Blank, the chief program officer at the Association of Public Health Laboratories told The New York Times that it is more likely to take “a couple of weeks” for one million tests to be deployed.

“The process of getting a test kit out and putting it into production is not something that happens literally overnight, in particular when you’re talking about a million tests,” he said. “It’s a nice thing to say, and it’s a simple thing to say, but the reality is we are a couple of weeks away from being able to deploy a million tests through this process.”

Concerns of community spread of the virus across the United States continue to escalate, with at least 12 states across the country reporting cases. Washington state—one of the states most impacted by the virus so far—confirmed 27 cases and nine deaths as of Tuesday.

Cases have also been detected in Arizona, California, Florida, Georgia, Illinois, Massachusetts, New Hampshire, New York, North Carolina, Oregon, Rhode Island, and Wisconsin.