About a month after Bill Gates criticized President Trump's decision to suspend funding to the World Health Organization (WHO), the federal government has just halted a Seattle-based COVID-19 testing program backed by Gates.
What are the odds, right?
"Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the Food & Drug Administration (FDA) wrote in a memo, addressed to the Seattle Coronavirus Assessment Network (SCAN), according to The New York Times.
SCAN posted an update on its website on Thursday (May 14) describing how the FDA had asked it to "pause" testing while it receives further guidance on new procedures for its COVID-19 test kits that collect samples at home.
The FDA "recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests," the post read.
"The FDA has not raised any concerns regarding the safety and accuracy of SCAN's test, but we have been asked to pause testing until we receive that additional authorization."
An FDA spokesperson told The Times, the home collection test kits raised some concerns about "safety and accuracy that required the agency's review."
The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them.
The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.
"We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.
SCAN is backed by The Bill and Melinda Gates Foundation and the University of Washington Medicine. The testing program was sending free test kits to participants' homes in the Seattle Metropolitan Area, with the goal of testing people in the region to get a sense of how the virus was spreading through the community.
More
DelMarVa's Premier Source for News, Opinion, Analysis, and Human Interest Contact Publisher Joe Albero at alberobutzo@wmconnect.com or 410-430-5349
Rules rules and more rules.
ReplyDeleteI got cross eyed reading this article. FDA has different standards for surveillance and diagnostic testing.
HELLO FDA - when was the last time a PANDEMIC hit the country? 100 years ago BEFORE you existed.
FDA rules have exceptions - 21st Century make it happen - IF GATES TESTING WORKS. Now if it doesn't - ok then.
Still need to update rules.
Bill Gates of Hell, no thank you. Flunky, no medical expertise, not a doctor.
ReplyDelete9:24 sure as hell smarter than you lol
ReplyDelete9:18 reading is hard without pictures. The country is suppressing testing because universal testing would show just how botched the response truly was.
ReplyDelete924 he is just resourcing the venture...
ReplyDeleteI don't care if he's a nutjob but if he is resourcing something that can help all?? Fine.
Yes BUT what else are they using this information for? If info 8s not correct we go back to stay at home again.
Delete9:18 You need to look into what Bill Gates along with Dr. Falsie have been up to.
ReplyDeleteThey both want "their" vaccine for ALL.
This plandemic has been all about $$$$$ from the start.
I'm shocked the FDA pushed back a little but it's a good first step.
Because we can't be trusted to make our own decisions and God forbid let us learn the results that may be of OUR concern!
ReplyDeleteNo thanks Bill Gates, you're not a doctor and I don't trust you with any of my DNA.
1006 yeah I get our point.
ReplyDeleteAll about the Benjamins.
Gosh I'm getting old.....but still alert!
With my bourbon!!!!!!!!!!!!!!!!!!!!!!!
ReplyDeleteSeems to me that Gates & crew launched this, with good intent, to try and capture a genuine cross-section of local population to get a better handle on who is/was sick, and who has been exposed. But I can see concern about samples coming back in regular mail, and about whether John Q Public took and packed the sample correctly. So it's more of a drag your brakes than a shut off the car note.
I am against home testing but It's imperative that any tests go through stringent testing. There is too much room for false negatives. If someone tests negative they are going to spread it to others.
ReplyDelete11:19 Gates only intentions is lining his and the foundations pockets. You can bet both are heavily invested financially in any company they "partner" with.
ReplyDeleteI don't believe Gates has done anything intentionally - but, I do believe he has a motive - ego - Power. He has more money then he can spend.
ReplyDeleteFDA has yet to approve Ibuprofen, Tylenol, aspirin for public use?
ReplyDelete