Ann: PromarkerD application for Australian MBS to be resubmitted, page-37

And furthermore,

NICE conclusion states "long-term cost savings would be materialised only if adopting the test reduces the number of people who need end-stage renal failure treatments."

Now look what MSAC said:

"MSAC noted that the applicant also agreed to removing the retesting suggestions for people with moderate- or high-risk scores. Retesting would now be restricted to patients assessed as low-risk of developing DKD by the test and their retesting interval would be restricted to a minimum of four years."

Read that carefully, NICE said it would only save costs if it reduced the number of people who need end-stage renal failure, and then PIQ agreed with MSAC that they need to re-model their economic study to only test low risk patients.

There are so many inconsistencies with PromarkerD, you have Richard spinning marketing BS about 86% accuracy and high PPV but when you look at the clinical results from each of the studies, the PPV has widely different from 34% in one study to 74% in another. The underlying issue with PromarkerD is obvious - they need REAL WORLD clinical data and this is where Sonic will probably play a part. Sonic will provide the infrastructure to recruit and do a study to collect real world clinical data. This would explain why FDA submission has fallen by the way side. But the problem here is the patent expires in 2031!