RE: Going nuts on twitter10 Sep 2021 18:27
Bigbangs, I indicated the RNS was misleading IF ODX has applied for self-test (which the big noise on twitter today was suggestive off). Having confirmed that there is no self-test FDA EUA application, The RNS was and remains 100% accurate, they have applied for professional use only. The tone of the comment I received from walbrook indicates that they are only in the stages of checking what is required for home use. The bit I find disingenuous is the tone of the tweets today and the implication that FDA approval opens the doors to access to this massive 100M user group. Add in the suggestion from elsewhere that USA gov will be ordering starting to order almost immediately, and people are frothing unrealistically, but driven by the tweets.
"It occurs to me that we often talk about the holy grail test that receives home use approval. Has anybody actually used a qualifying test and is it much easier to use that the tests we are familiar with?"
Ease of use is not the issue per se. Unless it is approved for self-test, then these can not legally be distributed to the 100M US employees to do their own testing twice a week at home or in their own office etc. They must be used/supervised by a "professional" (i.e. at the least someone of some medical/testing level trained it in).
I fully expect the uni study to show good results, ODX is hardly going to submit for CE with a study with bad data. But the FDA will have it's own rules and criteria for these things. Unless someone has some relevant knowledge here, we have no way to assess how long self-test EUA might be behind professional, all we know is that as of today, the test has not been submitted for self-test use. And in reality we are hoping that professional use arrives shortly.
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