Posted on 04/16/2020 10:35:03 AM PDT by rintintin
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
Everlywell Inc., of Austin, Texas, had announced March 18 that it had a test kit available for shipment that would have permitted at-home collection of samples that could have been analyzed via telehealth. The company indicated it had 30,000 such kits available, but the company had to withdraw the direct-to-consumer offer. The kits are available to health care professionals.
Among the companies that have shelved plans to distribute kits to consumers is Nurx Inc., of San Francisco, which had partnered with Molecular Testing Labs of Vancouver, Washington, to develop the tests. Other firms have flirted with the at-home market for these tests, including Carbon Health, also of San Francisco, which likewise stood down a similar plan.
The FDA discussed briefly its position on at-home testing in a FAQ for coronavirus diagnostics, stating that its policy for COVID-19 testing excluded at-home testing and self-collection samples. The agency encouraged developers to discuss their validation efforts for such tests “early in their development process.”
Danielle Bradnan, an associate with Lux Research Inc., of New York, described the FDA’s position as "baffling.” Bradnan said that while the FDA “is trying to achieve a delicate balance, trying to facilitate as many tests as possible while ensuring safety and accuracy, it is unclear why it is doing this.”
Test samples must be shipped to an independent, CLIA-certified lab for many test collection sites, Bradnan said, adding that the process in question “is identical to the process of at-home testing companies
(Excerpt) Read more at bioworld.com ...
There are really only two things government is good at:
1) Killing people
2) Selling monopolies
They are not about to give up either of those things.
The government wants your DNA....period.
There’s nothing preventing people from ignoring positive results of a COVID-19 home test for example, especially if there’s a party tonight.
Insights welcome.
“The government wants your DNA....period.”
Then why are they slow-walking other testing processes and protocols? FDA and CDC have been slow-walking the roll-out of testing for two months.
yip
You bet they do. This is a golden opportunity, they aren’t about to let it slip away.
“There’s nothing preventing people from ignoring positive results of a COVID-19 home test for example, especially if there’s a party tonight.”
So you’re defending the FDA’s blocking of tests? Because hey, tests don’t matter anyway? The bureaucrats LOVE folks who come up with creative defenses for them! I’m sure they’re saying, “why didn’t we think of that excuse for our inaction, arrogance and blundering”?
” This is a golden opportunity, they aren’t about to let it slip away.”
They have been blocking the development of tests for two months. I don’t see them as seizing any opportunities, except for the opportunity to remind people that they’re the bosses.
I just want access to a highly accurate serology test that will tell me whether I have a crap-ton, a few, or no COVID-19 antibodies.
Allowing people to self-test means giving up power.
Guess I won’t be getting tested.
There is nothing that prevents you from ignoring positive results of a Wuhan-400 home test now.
Do you think they put an ankle monitor on you to see that you go home?
Maybe I should not give them ideas.
It will be the largest nationwide database ever created and a golden opportunity for the government.
They'll insert what they already have,,,with some blank spaces.
The FDA , almost more than anybody else , has been completely exposed during this whole episode
They are slow and bureaucratic and filled with Government-idiots
They are used to plodding along , doing research writing papers and giving talks
This whole thing forced the fire to be lit under their ass and they just started scrambling
and of course , Trump got quickly fed up with them ! and just went right over their heads to Abbott laboratories and Bayer and and all the great minds of pharmacology and pharmaceutical industry
and just totally bypassed them.
They’re still trying to show that they have some relevance but I’m reminded of the famous quote that the government is the”c”’ people of the world
Are the kids in school who got C’s and just got a long barely got by but passed
Government doesnt trust citizens.
But govern,ent demands we trust government.
Phruck government.
>>There’s nothing preventing people from ignoring positive results of a COVID-19 home test for example, especially if there’s a party tonight.
The Left has repealed laws requieing those with HIV/AIDS to disclose their disease status to potential sex partners. Informed consent, what’s that?
Some diseases are more equal than others. AIDS PRIDE.
>>There’s nothing preventing people from ignoring positive results of a COVID-19 home test for example, especially if there’s a party tonight.
There were people who’d had their CV19 positive status confirmed by hospitals and still they flew anyway.
. . . but there are ironclad prohibitions againstlying to a FISA courtclandestinely analyzing the blood sample you gave at the doctor’s office to get it.How could there be a problem!
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.