FDA Issues Emergency Approval for Coronavirus Test
The federal government has issued an emergency order allowing its coronavirus test to be used by state health labs nationwide, speeding up efforts to detect and contain new cases of the mysterious new illness.
Since the first cases of the pneumonialike virus were confirmed in the U.S. last month, the test could only be done at the U.S. Centers for Disease Control and Prevention’s own labs.
But the rapidly growing outbreak, which is concentrated in China, has since been declared a public health emergency in the U.S. as officials race to keep the number of cases in this country as low as possible.
“This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration, said in a statement Tuesday.
Test kits were expected to be shipped to more than 100 labs across the U.S. within the next few days. Starting next week, potential new cases will be confirmed by those labs directly, instead of the CDC, the federal agency announced Wednesday.
Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said the new measures would “greatly enhance” the government’s capacity to test and treat new cases and will set the path for the kits to be available commercially in the near future.
The newly discovered virus has sickened 11 people across five U.S. states _ Arizona, California, Illinois, Massachusetts and Washington. But the number of confirmed cases in mainland China was close to 25,000 on Wednesday, with 490 deaths.
Most of the patients affected so far are from central China’s Hubei province, where the virus-stricken city of Wuhan is located. The first confirmed cases are linked to a large animal and seafood market in that city, though the exact source of the virus remains unknown.
The viral infection can cause respiratory illness and most patients have developed mild symptoms, such as fever and cough.
Even as they declared the outbreak a public health emergency last week, U.S. officials insisted the threat to the general public remains low because there’s no evidence the virus is spreading in this country. Nearly all U.S. patients had recently returned from China when they were diagnosed with the disease.
U.S. travelers returning from China have been quarantined at military bases. Messonnier on Wednesday said four more planes carrying passengers from Wuhan are making their way into the U.S. Two of those planes are heading to California, one is going to Nebraska and the other is bound for Texas.
“We do not believe these people pose a threat to the community where they’re being held,” Messonnier told reporters in a phone briefing, noting that CDC agents would screen those travelers immediately upon arrival.
As of Wednesday morning, the CDC has tested nearly 300 suspected cases. Seventy-six of them were still pending while 206 came back negative, including one at Manhattan’s Bellevue Hospital.
(c)2020 New York Daily News
Visit New York Daily News at www.nydailynews.com
Distributed by Tribune Content Agency, LLC.
In The News
In The News
WASHINGTON — House Ways and Means Chairman Richard E. Neal's attitude toward legislating under a Democratic-led White House might aptly be described as "never let a crisis go to waste." The Massachusetts Democrat wants to take a page from his party's 2009 playbook, when the Obama administration took office amid the wreckage of... Read More
WASHINGTON — When the 117th Congress convenes in January, COVID-19 precautions will prevent the 435 House members from gathering in the chamber together, so opening day festivities of swearing in members and electing the speaker will look a little different. House leaders have begun discussing how to carry out... Read More
WASHINGTON — Treasury Secretary Steven Mnuchin will put $455 billion in unspent Cares Act funding into an account that his presumed successor, former Federal Reserve Chair Janet Yellen, will need authorization from Congress to use. Mnuchin plans to place the money into the agency's General Fund, a Treasury Department spokesperson said Tuesday. That fund... Read More
WASHINGTON — Top appropriators reached bipartisan agreement Tuesday on a framework for an omnibus spending package that would avoid a partial government shutdown next month. The compromise forged between the leaders of the House and Senate Appropriations committees sets spending allocations for the dozen bills that fund federal agencies... Read More
WASHINGTON — President-elect Joe Biden will begin to get the nation's most classified intelligence after the White House signed off Tuesday on providing him the Presidential Daily Briefing as the transition moves forward. The incoming president getting access to the top-secret briefing is the most high-profile part of the transition and... Read More
WASHINGTON — A top Senate Democrat said Tuesday that she's engaged in bipartisan discussions on COVID-19 aid and urged quick action even if that means "a short-term package for the next few months." "We need to act," said Sen. Debbie Stabenow, D- Mich., the fourth-ranking Democrat in that chamber... Read More