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Coronavirus: FDA issues emergency approval for new Covid-19 test that works 10 times faster

'We are increasing the speed definitely by a factor of 10'

Chris Riotta
New York
Friday 13 March 2020 15:36 GMT
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Harvard professor calls US coronavirus response a 'catastrophic failure'.mp4

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The US Food and Drug Administration (FDA) has granted emergency approval for a new coronavirus test that promises to vastly increase the speed and rate of testing across the country, according to officials.

The new tests run on the pharmaceutical company Roche Holding AG’s cobas 6800/8800 systems, which, according to Bloomberg News, are capable of performing 4,128 and 1,440 tests daily, respectively.

Thomas Schinecker, who leads the company’s diagnostics unit, told the news outlet in an interview: “We are increasing the speed definitely by a factor of 10.”

“We definitely extended the capacity of the testing significantly throughout the US”, he added.

The company’s shares were 11 percent above their normal rates after news of the FDA’s decision to grant emergency approval for the tests was reported on Friday, according to Bloomberg News.

The pace of US testing for the highly contagious virus that is sweeping the world has been heavily criticised. Donald Trump said on Friday that testing in the United States will soon happen on a large scale, but did not provide any details.

On Thursday, the top US official on infectious diseases, Anthony Fauci, told Congress that people cannot get tests for the coronavirus easily and the US testing system is not meeting the country's needs.

The United States has tested a much smaller percentage of people than other major countries with significant outbreaks of coronavirus, which can cause the sometimes fatal COVID-19 respiratory illness.

Dr Fauci told MSNBC he expects to see testing availability ramp up within a week.

The New York State Department of Health can authorise certain laboratories to begin testing for the coronavirus, the FDA also said on Friday.

The agency is granting this flexibility due to the urgent public health need for additional testing capacity in the United States. Boosting testing capacity is crucial to assessing the scope of the US outbreak and identifying where it is spreading most rapidly.

More than 1,700 cases of coronavirus and at least 40 deaths have been reported in the United States, according to a tally by Johns Hopkins University and local public health authorities.

Reuters contributed to this report

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