The U.S. Food and Drug Administration (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.
The move was announced by the FDA on Feb. 29, as three of four new confirmed coronavirus cases on the West Coast indicated community spread of the virus across the United States.
The first American to die from coronavirus, was a man in his 50s with underlying conditions in Washington state, officials said Saturday. A second American, a man in his 70s with underlying health conditions, also died on Saturday after contracting coronavirus, according to a Sunday
press release from Seattle and King County Public Health.
As of March 1, 88 cases of the novel coronavirus had been identified in the United States, with New York’s first case
confirmed on Sunday.
The policy change also came as FDA Commissioner Stephen Hahn
joined the White House coronavirus task force. The government is scrambling to reassure Americans of the nation’s preparedness while the disease spreads, and businesses cancel conferences and flights.
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.”
U.S. Health and Human Services Secretary Alex Azar told
ABC’s “This Week” on Sunday that the United States now has 75,000 test kits for coronavirus and will expand that number “radically” in the coming weeks.
“Right now, it’s important that we test people who have any type of respiratory illness—respiratory symptoms—that is unidentified,” Azar said.
More than 3,600 people have been tested for coronavirus across the United States, Azar said. The U.S. Centers for Disease Control and Prevention (CDC) has tested fewer than
500 cases, according to official figures.
A Surge in US Coronavirus Cases Expected
Public health officials have said the increased testing will likely result in a surge of confirmed coronavirus cases across the United States.
More than 40 public health laboratories are expected to be able to test for coronavirus by the end of this weekend, according to Scott Becker, the head of the Association of Public Health Laboratories. This figure, Becker added, should grow to more than 100 laboratories over the next week as the CDC sends out more test kits.
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.
“I certainly do wish that the testing was available sooner. There was this very unfortunate challenge in the production process, and it did put us a few weeks behind,” Becker told
NPR, adding that the United States is “going to start to see more and more cases pop up across the country.”
“We'll have a much greater understanding of what’s going on with the virus here in America,” he added.
Vice President Mike Pence told CNN’s Jake Tapper on Sunday that more coronavirus deaths in the United States were “possible.”
“We could have more sad news,” he
said. “But the American people should know the risk for the average American remains low.”
Reuters contributed to this report
