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FDA shuts down at-home tests for COVID-19
Howard Richman, 3/23/2020

Proving again that they are part of the problem, not part of the solution, the FDA on March 21 shut down the at-home tests for COVID-19 that had been developed by several companies according to techcrunch.com:

While a number of companies who currently offer at-home medical and health diagnostics had rushed to produce kits that would allow for self sample collection by people who passed a screening and believed they might have contracted the new coronavirus, the U.S. Food and Drug Administration  (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically bar the use of at-home sample collection. This means startups including EverlywellCarbon Health and Nurx will have to immediately discontinue their testing programs in light of the clarified rules.

The FDA issued the updated guidance on March 21, and though some of the companies had already begun to ship their sample collection kits to people, and even begun to receive samples back to their diagnostic laboratory partners, even any samples in-hand will not be tested, and will instead be destroyed in order to comply with the FDA’s request....

All three of the companies we spoke to that were working to distribute these tests had partnered with labs that were approved under the FDA emergency guidelines to perform COVID-19 diagnostics, and it was the understanding of all parties that at-home self collection via swab kits was included in the authorization. All three also said they were offering their tests at-cost, and seeking ways to defray even that cost to consumers through potential healthcare agency partnerships. Each also offered telehealth consultations for both the sample-gathering process, as well as for delivery of the results.

My son and I called it "injelitance" which occurs when incompetents rise to power who are skilled only in the arts of preventing problems from being solved by the capable. In this case, the FDA was shutting down the attempts by capable entrepreneurs to solve the problem of unavailable COVID-19 testing. So why did the FDA do it? They claimed that at-home testing would not be sufficiently accurate:

The FDA’s goal with its emergency use authorization is to enable testing without sticking to its usual qualification process, but it must always balance accuracy and safety. It did grant emergency use approval to Cepheid’s rapid point-of-care test last Friday, as well, which should expand availability of tests on-site in locations like hospitals and emergency medical care clinics, but this updated rule means that at-home tests will not, in the near-term, be a path towards expanding testing coverage in the U.S.

It is apparent to everyone, but the bureaucrats at the FDA, that the safest place for people to get tested during an epidemic is in the home where they don't have to expose themselves to the disease. The private sector was solving the problem, so the injelitants in charge of the FDA had to stop them.

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Comment by robert, 3/29/2020:

I hope this coronavirus goes down soon. please god 




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