Washington - 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 Centre for Devices and Radiological Health, said in a
statement.
The World Health Organisation 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 US 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
1:30pm 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 US Centres 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 US 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.