I believe that Jod is correct. The FDA should conclude the PMA approval after they finish inspecting the laboratory processing facility. Given that it is a processing site, not manufacturing, and the demonstrated discipline at EXAS, I suspect that this should be as much a slam dunk as the approval itself. I am sure EXAS and the FDA are also finishing dotting the "i"s and crossing the "t"s for an ongoing supplemental study to fine-tune the best recommended frequency for Cologuard screenings, every 2, 3, or 4 years. Personally, I will do a Cologuard screening every two years; that would only be an annual cost of about $250 a year, including the physician cost. That's cheap to eliminate the risk of CRC and avoid the costs, interference, and risks of colonoscopies.
Let's see, $250 a year = two tanks of gas for my truck or a quick trip to Costco or one dinner out with my wife and adult kids. Ya, that does seem pretty cheap to eliminate the risk of colon cancer. Good call senior. Maybe this year for Christmas i'll give gift cards for Cologuard to friends and family.
I would like to see the distribution of those approvals by type. I would presume that the average elapsed time is biased upwards by difficult or negative decisions, but I am not sure. I am still betting July or August.