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!
(20min delay)