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FDA authorizes first rapid, 'point of care' coronavirus test
The Hill ^ | 03 21 2020 | Nathaniel Weixel

Posted on 03/21/2020 10:46:37 AM PDT by yesthatjallen

The Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.

The test from California-based Cepheid will deliver results in about 45 minutes – much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.

The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions like HIV or tuberculosis.

The systems do not require users to have specialty training to perform testing, and are capable of running around the clock.

"An accurate test delivered close to the patient can be transformative — and help alleviate the pressure" that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid's chief medical and technology officer, said in a statement.

"People in general are frustrated with the turnaround time. They don't know their status until days later. Knowing your status quickly ... this will allow much better decision making" and help doctors decide which treatment is best, Persing said in a video on the company's website.

SNIP

(Excerpt) Read more at thehill.com ...


TOPICS: News/Current Events
KEYWORDS: chinavirustest; coronavirus; fda; testing
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Private industry comes through again.
1 posted on 03/21/2020 10:46:37 AM PDT by yesthatjallen
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To: yesthatjallen

Where can I find one? Do I need a prescription?


2 posted on 03/21/2020 10:50:01 AM PDT by immadashell (Save Innocent Lives - ban gun free zones)
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To: yesthatjallen

You can bet the FDA will move lightning fast to approve tests
which will of course make the number of cases skyrocket and they will move at a crawl to approve any possible cure.


3 posted on 03/21/2020 10:51:15 AM PDT by gibsonguy
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To: yesthatjallen

Great!

Now they need to come up with cheap “at home” tests for both CV and the flu.

They have home flu test but they cost more than $300.

Then armed with knowledge of what you have, you can call the doctor and make arrangements.


4 posted on 03/21/2020 11:08:04 AM PDT by DannyTN
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To: gibsonguy

“and they will move at a crawl to approve any possible cure.”

no approval is needed by anyone to utilize existing drugs for other purposes ... once a drug is FDA approved for usage, it can be used for pretty much anything medical doctors and researchers discover it’s useful for ... it’s called off-label usage, and it’s legal and it’s ethical and people would be shocked at the number of prescriptions they take that are off-label, as new uses for existing drugs are constantly evolving WITH NO NEED FOR FDA APPROVAL ...


5 posted on 03/21/2020 11:11:49 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: DannyTN
“At home test kit. “Reminds me of those home pregnancy tests. 🤔
6 posted on 03/21/2020 11:13:13 AM PDT by Redcitizen (Nobody needs a 10 round magazine. You need a 30 round magazine.)
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To: yesthatjallen

Have they got a test yet that doesn’t require shoving a swab to back of the cranium to get a sample?


7 posted on 03/21/2020 11:16:15 AM PDT by Bob434
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To: immadashell

Go ahead and get a 5” reinforced swab jammed in through your nose. I won’t.


8 posted on 03/21/2020 11:16:26 AM PDT by steve86 (Prophecies of Maelmhaedhoc O'Morgair (Latin form: Malachy))
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To: catnipman

Good point. If an existing drug can help it will be huge.


9 posted on 03/21/2020 11:17:33 AM PDT by gibsonguy
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To: yesthatjallen

i suspect that as high throughput testing gets underway, we’re probably going to see that hundreds of thousands of us
are walking around with covid-19, and therefore be able to determine the true mortality and hospitalization rates ...

once we find out that there’s not going to be any “surge” that will overwhelm our medical system and that
it’s pointless to quarantine most people anymore because way too many cats are out of the baf, we can stop all of this nonsense and get back to the business of business ...

as i write this, it dawns on me the above may be what President Trump is really thinking when he keeps saying
“we’ll see what happens in 14-15 days” and “the economy will come back very quickly” ...

if the above is true (and i suspect it is), then the stock market will indeed explode almost overnight in a couple of weeks or so, so now (or very soon) is the time to buy back into the market in a once in a lifetime opportunity for those with brave souls ...


10 posted on 03/21/2020 11:17:52 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: immadashell

Article says “The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems”

Looking up the machine, they cost $24,000 to $79,200, so my guess is that only hospitals have the machine.


11 posted on 03/21/2020 11:21:52 AM PDT by PapaBear3625 ("Those who can make you believe absurdities, can make you commit atrocities." -- Voltaire)
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To: gibsonguy

” If an existing drug can help it will be huge.”

absolutely ... especially if it’s an old drug that’s be around for 50 years, is cheaper than dirt, and whose toxicity profile is well understood ... obviously i’m thinking of hydroxychloroquine, which has a growing amount of anecdotal evidence that it’s effective against COVID-19 ... so let’s all pray that’s true ...


12 posted on 03/21/2020 11:22:11 AM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: immadashell

You first need symptoms.


13 posted on 03/21/2020 11:26:32 AM PDT by Balding_Eagle ( The Great Wall of Trump ---- 100% sealing of the border. Coming soon.)
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To: yesthatjallen

Was on FR a few days back.

Utah company’s COVID-19 test gets FDA go-ahead, set to distribute 50K per day a few days back.

Co-Diagnostics, Inc Receives CE Mark for Novel Coronavirus Test February 24, 2020
CE-marking as valid regulatory approval, and is now available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility

Approved and sold in the EU but our FDA needs more time to look at it!!!!

http://codiagnostics.com/co-diagnostics-receives-ce-mark-for-covid19test/


14 posted on 03/21/2020 11:33:35 AM PDT by DUMBGRUNT
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To: gibsonguy

The cure is chloroquine ..... so there’s that


15 posted on 03/21/2020 11:37:58 AM PDT by Dick Vomer (2 Timothy 4:7 deo duce ferro comitante)
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To: immadashell

I want to know where I can get a test to see if I have already had the virus.


16 posted on 03/21/2020 12:17:12 PM PDT by Pining_4_TX (The Nazis were socialists, and all socialists turn into Nazis.)
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To: PapaBear3625

Darn. I was hoping they’d be available at grocery stores like RedBox movie vending machines.


17 posted on 03/21/2020 12:24:31 PM PDT by Afterguard (Deplorable me!)
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To: Pining_4_TX
I think you'll need a serological test for that.

I'd line up for one of those.

So would hubby. He'd like to get the bleep back to work if we've had it already.

18 posted on 03/21/2020 12:27:04 PM PDT by mewzilla (Break out the mustard seeds.)
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To: mewzilla

Not having a serological test already....something else we can thank the expletive-deleted ChiComs for.


19 posted on 03/21/2020 12:28:35 PM PDT by mewzilla (Break out the mustard seeds.)
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To: mewzilla

If you find out if they are available and where, please let me know. Our entire family had a weird virus in February that we thought was flu, but it didn’t seem like a typical flu. Our main symptom was a horrible cough. I have asthma, and it went right to my lungs.


20 posted on 03/21/2020 12:31:26 PM PDT by Pining_4_TX (The Nazis were socialists, and all socialists turn into Nazis.)
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