lol .... so you saying "13 years of research by the CSIRO, then...

lol .... so you saying "13 years of research by the CSIRO, then 4 years with Rhythm to ultimately identify 1 lead protein bio marker and 4 adjunct markers (all non-DNA = low cost test) resulting in 91% specificity and 81% sensitivity" which in your opinion is significantly high then why going without FDA approval ?

Do you know what will be price difference in test with or without FDA approval ? just look at all the cheap off internet stool test sold in USA through alternative pathway for as cheap as $15 compare to FDA approved test ?

if you know all this and still supporting management idea of going without FDA approval says you probably singing management song and not giving any independent opinion ..... all in my opinion... !!