FDA to allow some labs to use coronavirus tests prior to review

The U.S. Food and Drug Administration (FDA) on Saturday said it will allow some laboratories to immediately use tests they have developed and validated to achieve more rapid testing capacity for the coronavirus in the country.

The policy cleared the way for state public health labs to immediately begin local testing and possibly get results within hours, which public health officials say will be critical to a rapid response to the fast-spreading virus that originated in China.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The World Health Organization on Friday said the virus, which causes a sometimes fatal respiratory illness and has spread to 46 countries, poses a “very high risk” at a global level.
On Saturday, New York Governor Andrew Cuomo said his state would immediately begin using its own test kit developed in-state. The state’s Department of Health on Friday filed an emergency application with the FDA to request permission to do so.
“We just received word that our test has been approved by the FDA. New York State will begin testing immediately at Wadsworth Lab,” the governor said in a statement, referring to the state’s lab in Albany.
New York’s public health lab was the first in the country to seek emergency authorization from the FDA to use its own testing kits after health officials said faulty tests from the federal government left them unable to diagnose people quickly in New York City, the nation’s most populous city.
There are 62 confirmed cases of the new coronavirus in the United States. Most of the people infected fell sick while abroad and before they were repatriated. No cases have been detected in New York City, but Mayor Bill de Blasio and health officials have said its arrival in the city is inevitable.
The weeks-long struggle to expand local testing has been criticized as an early misstep in the response by U.S. President Donald Trump’s administration to the outbreak.
Trump, who earlier this week described the risk from the coronavirus as “very low” in the United States, said on Twitter he will hold a White House press conference about the virus at 1:30 pm EST (18:30 GMT) on Saturday.
Three weeks ago, the FDA gave the green light for state and local labs to start using a testing kit developed by the U.S. Centers for Disease Control and Prevention (CDC).
But most labs that received the kits complained they had faulty components and produced inconclusive results, which the CDC later acknowledged.

Meanwhile, the CDC has been working to manufacture new kits that produce more reliable results.
In a hearing before the U.S. House of Representatives Ways and Means Committee on Thursday, Health and Human Services (HHS) Secretary Alex Azar said a newly manufactured CDC test could be sent to 93 public health labs as soon as Monday.
https://www.reuters.com/article/us-china-health-usa-fda/fda-to-allow-some-labs-to-use-coronavirus-tests-prior-to-review-idUSKBN20N0R6