Tests require at least 80% accuracy, which isn't the problem for...

Tests require at least 80% accuracy, which isn't the problem for ATOMO. Given their test is approved for health practitioner use, it seems likely to me that the hold up is more about the user-friendliness (or otherwise) of instructions to ensure this same accuracy level in the self-administration population. Perhaps more data from a self-administration study was requested. I'm also frustrated by the delay....but I do have faith it will be approved eventually and that the market is big enough for even the late comers.