FDA authorizes coronavirus test that could drastically speed up screening

The Food and Drug Administration has issued emergency authorization for a new coronavirus test that will speed up screening for the deadly bug by tenfold, the Swiss diagnostics maker Roche said Friday.

The new tests can provide results in 3.5 hours and can produce up to 4,128 results each day — a boost to tests the manufacturer has offered until now, the company said.

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“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of the drugmaker’s diagnostics unit, told Bloomberg.

The “emergency use authorization” provided by the FDA clears the tests to be deployed in the U.S. and markets accepting the CE mark, which shows they conform to European standards.

The company said it is “going to the limits of our production capacity” to deliver as many of the faster tests as possible.

“The virus is infecting people in an exponential way. We knew we had to go to the high through-put systems,” Roche Diagnostics head Thomas Schinecker told Reuters. “This will help isolate patients who are infected, so you can keep the others healthy.”

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The tests will run through two of Roche’s diagnostics systems, the cobas 6800, which can process 1,440 samples per day, and the cobas 8800 that can do more than 4,100.

Worldwide, a total of 695 cobas 6800 systems are installed and 132 of the 8800s, with “more than 100” in the United States, the company said.

Roche is speaking with the CDC about deploying more systems where they are most needed, including in Washington state, where 31 of the nation’s 41 deaths have occurred.

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Testing for the novel coronavirus in the U.S. has been hampered by flawed kits distributed by the federal government in February, which gave some false results.

Now, the country is grappling with more than 1,660 infections. Globally, more than 122,000 people have contracted the deadly bug.

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