Yes, I saw that as well, and you are SPOT on....which leads me to my very own conspiracy theory (so to speak), which I have alluded to here at times, but for which I will now go into detail at the end of this post, thanks to your in-depth dissection of the FDA's release.
When the FDA talks about "at-home" test kits, they do not specify for the detection of Nabs, but then again, nor do they specify for the detection of the virus itself. They were, undoubtedly, deliberately vague as I don't believe the FDA was in some kind of a careless rush when they issued the News Release. Since they neither specify antigen at home test kits, nor specify antibody at home test kits, I guess we are left to assume that they are referring to both types of test kits (and, perhaps other types of at home test kits related to the pandemic at hand, if and whatever those other test kits might be). So at this point, it is kind of a glass half full/half empty scenario. But let's continue.....
In the second part, we see the phrase "Certain lab based and POC (point-of-care) antibody tests....(fully quantitative antibody tests).....
Keep in mind, Immunopass has 3 versions, or perhaps it is the same kit, but can be used in 3 different ways, depending on who and where it is being done. This was written up in a PR by AXIM (or maybe in the dialogue of a 10-K, or even on their website, at this point I don't recall), and personally, as an aside, I believe AXIM accidentally switched up the words quantitative and qualitative in one of their statements (if you do find what I am talking about, and you compare it to what I have written below, you will see what I mean):
1. A qualitative test that can be rapidly done at home and gives results of High/Medium/low.
2. A semi-quantitative test, that can also be done rapidly at home, but that gives a numerical range in its results, and
3. A fully quantitative test (I believe, using the same exact test kit), that can once again be rapidly done (and gives results in 10 minutes), but which must be done in a doctor's office, since the test kit must be placed in a hand scanner that now accurately reads the test results using some kind of spectroscopy (the hand reader is just too expensive and too complicated for the average person to be able to afford or use at home).
The beauty of Immunopass, that is different from every other antibody test kit that that the FDA has approved (EUA) to date, is that at no point does Immunopass require that the results be done by a trained lab technician....and that is "Yuge" and the reason why you have heard Immunopass being frequently referred to as "First in Class".
Now to my "conspiracy" theory:
I believe the unprecedented (ie: did any other company issue a PR soon after the FDA's News Release?) Press Release that followed 3 days after the FDA's announcement speaks volumes. It was truly a bold statement by AXIM, pretty much tying the FDA's News Release directly to Immunopass, almost as if the FDA's News Release was about Immunopass. A pretty "ballsy" thing to do, unless, perhaps, Johnny H was aware of something.......
Conspiracy Theory (and again, this is just from the deepest parts of my wild imagination):
I believe Johnny H and Empowered have had very private conversations with someone at the FDA regarding the timing of the EUA for Immunopass (hence the reason I put my date of 2/20/2022 out there, which for many here is way to far down the road - and the reason why I say "good things come to those who wait"). I believe (conspiracy theory) that the FDA has told AXIM/Empowered to begin production, since Empowered can (only) produce 1 million test kits per day, and I believe Empowered has been doing so since as early as the beginning of November. Therefore, by the time the FDA gives its EUA for Immunopass, there will be a stock pile of the test kits available for immediate distribution (as many as over 100 million test kits, if you use my 2/20/2022 date and 1 million kits produced per day) upon the issuance of the EUA, which exactly matches the "mass produced" requirement specifically stated in the FDA's announcement, AND in AXIM's PR.
NOTHING underhanded is going on here. The EUA will be issued, as it would have anyway, it is just that when it is issued, the FDA wants to make it look like they know exactly what they are doing (ie: not getting caught with their pants down, as was recently seen when the Federal Government allegedly pre-ordered 500 million COVID test kits, and instead we have people waiting on lines for 6+ hours to be tested). BTW, as an aside, imagine waiting on line with people for 6 hours, ALL of whom believe they may be infected with COVID (after all, that is why they are there, isn't it?)? Is that really where you want to be, for 6+ hours? who think they might have COVID? Is THAT not in itself the potential for a "super-spreader"? How many times have you heard of someone going to the hospital for some unrelated reason (say for an appendicitis), a hospital where all the really sick people are, and then getting sick with something else while they are there? (think, perhaps, "sepsis")?
Contrary to "popular" belief right now, I have been working hand-in-hand with government agencies my entire business career (35+ years). It is unfortunate that, at some point, you find someone at the end of a long and boring career who wants to "make a name for himself" by taking down the biggest fish and making him out to be public enemy #1. That being said, government employees generally like to cover their arse, and if you work with them and do what they want (no matter how ridiculous it may seem at the time), you are more likely to get to where you want to be.
In conclusion: Over the last 2 months+, every single EUA issued by the FDA has been for antibody test kits (all of which require lab technician intervention). If you were Johnny H, wouldn't you be pissed? Why isn't Immunopass getting approved? And if you were (rightfully so) pissed, would you issue a Press Release applauding the very agency that you should be pissed at?
Nope. There is something else that must be going on behind the scenes. Nothing nefarious, just something that will ultimately result in the issuance of an EUA that is inevitable, but just one whereby the timing is such that the government employees won't have egg on their face when they finally do so.
.....just my own little conspiracy theory......Go AXIM!
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