The US 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.
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On Friday, New York’s public health lab became the first in the country to seek emergency authorization from the FDA to use their own testing kits after health officials said faulty tests from the federal government left them unable to diagnose people quickly in the nation’s most populous city.
New York state’s Department of Health filed an emergency application on Friday with the US Food and Drug Administration (FDA) to be allowed to use a testing kit it has developed in-state, an official told Reuters on Friday.
There are 62 confirmed cases of the new coronavirus in the United States, most of whom fell sick while abroad then were repatriated. No cases have been detected in New York City, but Mayor Bill de Blasio and health officials have said its arrival here is inevitable.
The weeks-long struggle to expand local testing has been criticized as an early misstep in the response by US President Donald Trump’s administration to the outbreak.
Three weeks ago, the FDA gave the green light for state and local labs to start using a testing kit developed by the US 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 House Ways and Means Committee on Thursday, Health and Human Services (HHS) Secretary Alex Azar said a newly manufactured CDC test can be sent to 93 public health labs as soon as Monday.
Check out Al Arabiya English's special coverage on the coronavirus here.