I have been searching for and reading medical study reports over...

I have been searching for and reading medical study reports over the weekend. I've specifically been looking for studies that validate the effectiveness of protein bio markers (proteomics) for detecting advanced adenomas. Not surprisingly, there have been a lot of research studies and reports internationally in recent years, it's the Holly grail of CRC prevention! Most studies had positive conclusions, yes it is very possible for scientists to refine a panel of bio markers for this purpose. , but more work is needed. All of the studies I found had performed a single study on 100 or so patients. There was a strong preference for any future test to be ELISA compatible because it is the most accurate method for protein bio markers. I couldn't find a single study with results so outstanding that they were progressing to larger trials anytime soon. Certainly none had performed trials as extensive as Rhythm's.

My overall impression is that scientists across the globe are working on this, however it seems that Rhythm are the ones who have actually achieved it!

I imagine that Colostat's will speak for itself. They don't really need to go on the hard sell because they have a unique, advanced and proven test. TGA approval is the last piece of the validation puzzle, it's a highly regulated quality endorsement essentially. After this process is completed, I predict partners will be extremely enthusiastic!

For the record, FDA approval does not guarantee medical reimbursement. This is a separate process. EPI ProColon (DNA blood test) has FDA but was rejected for Medicare because it's results for advanced adenomas was no better thank FIT.

Here is a Sensitivity comparison -

FIT Advanced Adenomas - 27%
FIT Stages 1/2/3/4 - 60%-80% (highly variable due to only testing for blood in stool, prone to false positives)
COLOSTAT Advanced Adenomas "greater than FIT"
COLOSTAT Stages 1/2/3/4 - 81% firm, accurately tests for CRC