F.D.A. Expands Coronavirus Testing in the United States

F.D.A. Expands Coronavirus Testing in the United States

The Food and Drug Administration announced Saturday that testing for the coronavirus would be greatly expanded in the United States, giving laboratories and hospitals around the country the go-ahead to conduct tests that had until now been severely limited to those analyzed by the Centers for Disease Control and Prevention.

The decision should improve the pace of detecting coronavirus infections and make it possible to more rapidly spot patterns of suspected or confirmed cases. That could be most immediately valuable on the West Coast, where several new cases of unknown origin were reported in recent days.

“We’re not going to find what we’re not looking for, so lifting the restrictions on diagnostic testing will put a lot of minds at ease,” said Haley Holmer, an epidemiologist who happens to have a child at an elementary school in Lake Oswego, Ore., that is closed because a school employee was found to have been infected by the coronavirus.

Dozens of labs — run by states, universities and private companies — have applied for emergency approval for tests. Once they have submitted evidence that those tests work, they will be able to use them immediately, even before the F.D.A. to completes its review.

“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 F.D.A.’s commissioner, Stephen M. Hahn, said in a statement.

Public health experts and hospital officials around the country have expressed frustration in the last few weeks at the inability to test for possible coronavirus cases.

Until recently, the C.D.C. had insisted that only its test could be used on suspected cases, and only under limited circumstances — on people who had traveled to China within 14 days of developing symptoms or had contact with a known coronavirus case.

The Coronavirus Outbreak

  • Answers to your most common questions:

    Updated Feb. 26, 2020

    • What is a coronavirus?
      It is a novel virus named for the crownlike spikes that protrude from its surface. The coronavirus can infect both animals and people and can cause a range of respiratory illnesses from the common cold to more dangerous conditions like Severe Acute Respiratory Syndrome, or SARS.
    • How do I keep myself and others safe?
      Washing your hands frequently is the most important thing you can do, along with staying at home when you’re sick.
    • What if I’m traveling?
      The C.D.C. has warned older and at-risk travelers to avoid Japan, Italy and Iran. The agency also has advised against all nonessential travel to South Korea and China.
    • Where has the virus spread?
      The virus, which originated in Wuhan, China, has sickened more than 80,000 people in at least 33 countries, including Italy, Iran and South Korea.
    • How contagious is the virus?
      According to preliminary research, it seems moderately infectious, similar to SARS, and is probably transmitted through sneezes, coughs and contaminated surfaces. Scientists have estimated that each infected person could spread it to somewhere between 1.5 and 3.5 people without effective containment measures.
    • Who is working to contain the virus?
      World Health Organization officials have been working with officials in China, where growth has slowed. But this week, as confirmed cases spiked on two continents, experts warned that the world was not ready for a major outbreak.