There is no data out on the trial. Therfore any concerns you see are idle speculation from posters who don't present rational arguments as to why there will be a drop in sensitivity. Could it happen ? Yes. Is it likely, no. If you compare the last three validation studies the sensitivity numbers were very consistent and averaged around 58% for adenomas. If you look at the 95% confidence intervals then you would predict a lower limit of 45% (although that is unlikley). As far as the overall sensitivity to all cancers that only has to hit 70% - a target that should be easy to reach given that 85% was attained in the previous trial. At this point, without additional information it is just idle speculation. We will know soon enough since the CEO guided to March-April for results.
There are arguments that could be presented that would send the sensitivity higher or lower in the trial. But at this point, what is the use of coming up with hypotheticals since the real data will be out any day.
Isn't the comparison being made to same clinicians in the trial that would naturally have an edge in performing colonoscopy, and arguably a desire to continue doing so rather than be replaced by a test? I'm struggling to understand how a trial can be designed like this when the very goal of the therapy is to replace the actions of the doctors helping run the trial. What am I missing?
specificity was actually 87%; not 90% from Deep-C results; this means that on average 13% of positives from cologuard will actually be negative by colonoscopy. I would love to know how many of the false positives from cologuard actually eventually test positive; implication that colonoscopy has false positives too.