As I read the letter it is not a comment on the ef

As I read the letter it is not a comment on the efficacy of the test per se, but a failure to date to obtain the necessary approval to market in US. Short of approval Innova claims of effectiveness cannot be verified according to US standards. We already know that the vast bulk of marketing and sales is occurring outside the US. We were aware of some test applications within the US. I don't know if the few instances of "marketing" within the US this letter cites fall within this scope. I didn't see any mention of a concurrent approval process, which I thought was under way.