Posted on 03/18/2020 6:11:56 PM PDT by ameribbean expat
The company says it has the resources to produce 50,000 or more of the tests daily from its Salt Lake facility. Each test, according to the company, costs about $10 per patient, delivers results in about 90 minutes and can be processed at most medical labs.
During a community leaders call hosted Monday by Utah tech sector advocacy group Silicon Slopes, Co-Diagnostics communication director Seth Egan said his company has already earned approval from the European Union for its test, which uses a sputum sample to look for evidence of COVID-19, but continues to await action from the FDA under the agency’s expedited emergency use protocol for COVID-19 testing.
“With FDA approval through emergency use authorization we could supply all of the testing needs in Utah and around us easily,” Egan said. “We sit here a little bit amazed that we have a test available in European nations but we can’t sell it as a clinical diagnostic in our own home state.
(Excerpt) Read more at deseret.com ...
There was an earthquake there today. Is that still the case?
For Blondes, I hope it is clearly labeled that, “This is NOT a pregnancy test!!”.
Bookmark
Don’t know but FDA did change policy last night:
FDA- Foot Dragging Agency
What?
The test has not yet gone through the myriad bureaucracy demanded by the CDC?
Horrors.
After all, we KNOW that Dorkbama the Muslim eunuch quota boy would have demanded it.
It’s not the CDC.
It’s the FDA.
How do we know that these tests can distinguish between COVID-19 and other coronaviruses? There are lots of them.
Egan said. “We sit here a little bit amazed that we have a test available in European nations but we can’t sell it as a clinical diagnostic in our own home state.
Thanks to FDA and CDC, this bs continues.
Yes, there has been a fast test for this virus,, but our old rules concerning any test approval by the Obama/Biden thugs, kept this test out of America.
Thanks to President Trump that is changing.
Shares of Swiss drug maker Roche rise after FDA approval for corona virus test!
The company says the tests are able to provide results in 3-½ hours.
This approval for Roche means millions of tests a month will be available to help boost capacity for diagnosis of the flu-like virus.
Shares of Swiss diagnostics and pharmaceutical giant Roche rose 3% Friday after the U.S. Food and Drug Administration (FDA) issued emergency authorization for their COVID-19 test.
These highly automated tests, which the company says are able to provide results in 3-½ hours, can be run on Roche’s fully-automated machines which are already installed in hospitals and laboratories across the U.S. and around the world.
Roche was the first company to supply tests to diagnose the coronavirus in China.
The drug giant was able to lean on its experience dealing with the SARS virus outbreak which also originated in China. Speaking to CNBC in January, CEO Severin Schwan said the company’s focus was to bring the necessary diagnostic platforms and test to the point of care.
Testing for the virus is one of the primary concerns in the United States at this stage. According to the Centers for Disease Control and Prevention, a total of just over 11,000 specimens have been tested since January.
By contrast, a total of almost 30,000 people have been tested for the virus in the United Kingdom, while nearly 20,000 people are being tested for the virus everyday in South Korea.
This USA approval for Roche means millions of tests a month will now be available to help boost capacity for diagnosis of the flu-like virus.
Beyond diagnostics, Roche has also been involved in the fight against corona virus complications.
Earlier this month, China approved use of the Swiss drugmaker’s anti-inflammatory drug Actemra to treat patients with aggressive immune reactions to the virus.
Wonder if the Roche Diagnostic test was used on our president for his quick test results?
I agree. I consider the FDA one of the most corrupt agencies in government.
From all I’ve seen, the sole job of the FDA is to say “no”, a role they cling to jealously.
Plenty.
Maybe this is what Trump was alluding to for upcoming announcement.
Happens all the time. Tested and approved in Europe. Nope, can’t use in the US. Have to go back to square one and re test for FDA.
OTC in Europe and most places in the world. Nope, prescription only in the US. Diclofenate Sodium topical pain reliever, think of it as ibuprofen in a tube. $10 to $12 all over the world over the counter. Got to have a prescription for it here and it is $50 a tube or more. I bought Cipro by the box in Brazil and a tube of Zovirax. Dirt cheap, OTC.
FDA and CDC should be made to justify their very existence after this is over. CDC especially. Their work on this sucks.
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