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US Begins Crackdown on Unvetted Virus Blood Tests

posted by Fnord666 on Monday May 25 2020, @05:47PM   Printer-friendly
from the demonstrate-that-it-works dept.

upstart writes in with an IRC submission for chromas:

US begins crackdown on unvetted virus blood tests:

U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.

The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.

The agency said in a statement that it expects the tests "will not be marketed or distributed." It was unclear if any of the companies would face additional penalties.

Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a "Wild West" of unregulated testing.

[...] Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.

The FDA is now working with the National Institutes of Health and other federal health agencies to vet the accuracy of the tests and determine how they can be used to track and contain the virus.

Original Submission

 
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  • (Score: 0) by Anonymous Coward on Tuesday May 26 2020, @03:38PM (1 child)

    by Anonymous Coward on Tuesday May 26 2020, @03:38PM (#999242)

    I'm in the same boat, but boy am I glad I don't have kids. I might be able to weather self-quarantine if I got sick, but if I had a family to support, I'd be working sick or not - and duck anyone who says my child's food is less important than their safety.

  • (Score: 0) by Anonymous Coward on Tuesday May 26 2020, @10:13PM

    by Anonymous Coward on Tuesday May 26 2020, @10:13PM (#999397)

    And then you give the disease to your kids and they develop the child's syndrome of cardiac vessel inflammation and then you get to find out whether or not you ended up killing your kids by your feeling you needed to work to support them during this time.