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FDA grants emergency approval for faster coronavirus test

 

The U.S. Food and Drug Administration (FDA) has granted diagnostics giant Roche Holding AG an emergency approval for an automated coronavirus test, which the company said could increase testing tenfold for the virus that has reached pandemic levels.

 

The FDA granted an “emergency use authorization” to the test, which functions on Roche’s cobas 6800/8800 systems, Bloomberg News reported. The 8800 system can test up to 4,128 patients a day. The 6800 system can test as many as 1,440 a day, the Switzerland-based company confirmed. 

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

 

This is the first commercially available test granted emergency approval by the FDA. The agency approved diagnostic tools from the CDC and the New York State Department of Public Health last month.

 

Roche’s cobas systems are available around the world, according to Bloomberg News. There are 695 of the 6800 instruments and 132 of the 8800 systems installed. There are 110 of these systems in the United States, and the company said it installed a “significant amount” in the country in recent weeks.

 

The two systems are able to provide test results within four hours. The company said it is “going to the limits of its production capacity,” Bloomberg News reported.

 

The company declined to comment on pricing for the tests to the outlet. 

“We definitely extended the capacity of the testing significantly throughout the U.S,” Schinecker told Bloomberg News. The company also had an existing test for the coronavirus, but the cobas 8800 system can test patients approximately 10 times faster.

 

 

 

VIMTSTL
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Thankfully, those who do NOT reside in the Trump Alternate Reality Bubble of FAKE NEWS, utilize FACTS.

 

"The Trump administration recently requested $2.5 billion in emergency funds to prepare the U.S. for a possible widespread outbreak of coronavirus.. Critics, though, are pointing out that money might not be necessary if the administration hadn’t spent the past two years largely dismantling government units that were designed to protect against pandemics.

 

The cuts started in 2018, as the White House focused on eliminating funding to Obama-era disease security programs. In March of that year, Rear Adm. Timothy Ziemer, whose job it was to lead the U.S. response in the event of a pandemic, abruptly left the administration and his global health security team was disbanded.

 

That same year, the Centers for Disease Control and Prevention (CDC) was forced to slash its efforts to prevent global disease outbreak by 80% as its funding for the program began to run out. The agency, at the time, opted to focus on 10 priority countries and scale back in others, including China."

 

"The effects of those cuts are being felt today. While the CDC announced plans to test people with flu-like symptoms for COVID-19, those were delayed and only three of the country’s 100 public-health labs have been able to test for coronavirus."

 

https://fortune.com/2020/02/26/coronavirus-covid-19-cdc-budget-cuts-us-trump/

Honored Social Butterfly

The U.S. Food and Drug Administration (FDA) has granted diagnostics giant Roche Holding AG an emergency approval for an automated coronavirus test, which the company said could increase testing tenfold for the virus that has reached pandemic levels.

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Good news for our country.

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Honored Social Butterfly


@KidBoy2 wrote:
The U.S. Food and Drug Administration (FDA) has granted diagnostics giant Roche Holding AG an emergency approval for an automated coronavirus test, which the company said could increase testing tenfold for the virus that has reached pandemic levels.

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Good news for our country.


It is good that Trump is finally paying attention. Remember when he said there would be 15 cases and then none? The bad news is that he went on TV and gave completely incorrect information about his policies.  So, the next time this POTUS gives a speech from the Oval Office, should they run a disclaimer "do not act on anything he says until his staff verifies its accuracy" on the bottom of the screen? (sorry, ITYS syndrome again)

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Will this make up for the time lost on all the tests the Trump administration distributed which did not work?  Hint: No.  This is typical Trump administration, botch the initial rollout and then cut corners to try and make up for the time and money lost. 

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