FDA approves New York coronavirus test, developed after botched CDC tests

1010 WINS Newsroom
February 29, 2020 - 12:42 pm
Coronavirus test

Kena Betancur/Getty Images


NEW YORK (1010 WINS) -- The FDA has approved New York's coronavirus test, which the state started developing after tests from the Centers for Disease Control and Prevention proved unreliable in multiple cases.

"We just received word that our test has been approved by the FDA," Gov. Andrew Cuomo tweeted Saturday. "This will expedite wait time and improve NY’s ability to more effectively manage the coronavirus situation as it unfolds."

Cuomo said the approval came after he spoke with Vice President Mike Pence and urged him to approve the test.

This means New York will be able to test for the virus without having to send tests to the CDC in Atlanta.

Cuomo said New York State's Wadsworth Lab will begin testing immediately.

New Jersey and Connecticut also have federal approval to do their own coronavirus testing on patients.

BuzzFeed News reported that New York labs were working with the FDA on a coronavirus test after CDC testing kits across the country were either delayed or proved undependable in detecting the potentially deadly virus.


New York City Department of Health and Mental Hygiene Deputy Commissioner Demetre Daskalakis confirmed with BuzzFeed News that problems were found in the original CDC test kit, prompting the city and state to set out in developing their own genetic test.

Meanwhile, the CDC is working to fix its tests. The CDC expects the reconfigured tests to be available in dozens of labs by the end of this week. But labs in New York have decided to reject the tests altogether. They’re now working with the FDA to create their own tests—an unprecedented move.

“These labs have to make absolutely certain that these tests are accurate and safe for the public,” Scott Becker, CEO of the Association of Public Health Laboratories, told BuzzFeed News.

There are currently no known cases of the novel coronavirus, officially known as COVID-19, in New York State.

The CDC’s initial test kit was sent to around 100 state and city labs nationwide as well as overseas, but labs expressed confidence in only a handful of cases.

For example, a test in California took four days to approve because a woman’s symptoms didn’t meet federal diagnostic criteria. This Wednesday—a week after testing on the woman began—it was determined she not only had the virus but was also the first person in the U.S. to apparently contract it from “community exposure.” This means she had no known exposure to anyone sick and hadn’t traveled to China, the epicenter of the outbreak.

A CDC spokesperson said Thursday that part of the problems with the CDC test is that the criteria for testing patients changed as the California woman was being observed. He said it wasn’t only the CDC that was involved in deciding how to test the woman.

On Friday, the World Health Organization announced that the risk of the coronavirus is "very high at a global level." Amid growing fears over the coronavirus and its potential to spread in the U.S. and other places outside China, the Dow fell 350 points on Friday, capping Wall Street’s worst week since the financial crisis of 2008.

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