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[continue]...On Feb. 29, the Food and Drug Administration announced that it was relaxing the restrictions for the use of diagnostic tests for SARS-CoV-2 developed by laboratories in the United States that meet the certification guidelines for high-complexity testing. The new policy allows these laboratories to begin using in-house developed clinical tests for the virus before obtaining the agency’s approval through an emergency use authorization. The FDA noted that “Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness.” Laboratories developing their own tests are expected to apply for emergency use authorization from the FDA within 15 days.

Until the announcement, samples from throat and nasal swabs of possibly infected people were sent to public health agencies for testing with an assay developed and distributed by the Centers for Disease Control and Prevention through an emergency use authorization from the FDA.


Has this change by the FDA on February 29, 2020 been widely reported? This is great news and really good that Stanford University has its own test for patients at the university hospital.
1 posted on 03/08/2020 9:30:23 PM PDT by ProtectOurFreedom
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To: ProtectOurFreedom
"Anybody who right now and yesterday, anybody that needs a test gets a test. The tests are beautiful."

- Donald J. Trump

You gotta love this guy! : )

2 posted on 03/08/2020 9:53:20 PM PDT by UnBubba
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To: Whenifhow; null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; ...

p


3 posted on 03/08/2020 10:12:42 PM PDT by bitt ("Make yourself sheep and the wolves will eat you." Benjamin Franklin)
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To: ProtectOurFreedom

And, ON A BROADER NATIONAL FRONT, LabCorp and Quest Diagnostics have rolled out their tests.

https://www.sciencenews.org/article/coronavirus-testing-diagnostic-covid19-united-states

Remember, “if you build it, they will come”. Aren’t free enterprise and unshackled private industry great! EAT YOUR HEART OUT, ROD ROSENSTEIN’S SISTER.


4 posted on 03/08/2020 10:14:05 PM PDT by House Atreides (Boycott the NFL 100% — PERMANENTLY)
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To: ProtectOurFreedom
It is expected to deliver results within 12-24 hours.

The CDC kit produces results within four hours.

https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html

5 posted on 03/08/2020 10:23:59 PM PDT by TChad (The MSM, having nuked its own credibility, is now bombing the rubble.)
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To: ProtectOurFreedom
Due to COVID-19 all TCP apps are being converted to UDP
7 posted on 03/08/2020 10:32:13 PM PDT by Vendome (I've Gotta Be Me https://www.youtube.com/watch?v=BB0ndRzaz2o)
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To: ProtectOurFreedom

yeah, the FDA reg-relaxation regarding CMS and insurance reimbursement of privately developed COVID-19 testing instituted by pence’s task force is a REALLY big deal ...

Quest and LabCorp, the two giants in the U.S. med testing field have done what Stanford did: LabCorp has been able to test for COVID-19 since last Thursday (3/5/2020) and Quest will have theirs ready tomorrow (3/9/2020), so all this putative “shortage” of tests being promoted by the fake stream enemedia and the doom and FR gloomers who keep trying to incite panic on FR are full of shite!

https://www.fool.com/investing/2020/03/07/labcorp-and-quest-to-offer-coronavirus-tests.aspx


8 posted on 03/08/2020 10:53:40 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: ProtectOurFreedom

The msm hasn’t but other news sources have....


9 posted on 03/09/2020 1:12:31 AM PDT by Nifster (I see puppy dogs in the clouds)
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To: ProtectOurFreedom

Have not heard it.. thanks for posting. Now everyone who looks sick will ask for this. PCR tests are very expensive this has been an example on how regulations slow down everything. Roll back CLIA88 its not saving lives.


10 posted on 03/09/2020 1:15:03 AM PDT by momincombatboots (Ephesians 6... who you are really at war with)
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