To my knowledge, every test out there to date requires a healthcare professional to determine the results. They in turn are probably required to pass their individual counts on to the CDC. That is obviously how we get all those daily count updates on tests and results numbers.
Genviro eliminates the need for healthcare professionals. So, How will the CDC keep an accurate count? That may be the delay in getting the authorization.
Thinking out loud, suppose the results can only be read by a cell phone. An individual purchases a serial numbered test kit. Downloads an app, fills in there personal info and takes a picture of the test results. The phone then tells him the test results and passes the info on to the CDC.
Hopefully Genviro's authorization doesn't require such a move. It would however, be very helpful if the FDA told DECN what their though was.