The answer is in the ratified PICO report, a friend and I highlighted this to investors back in 2021 when it was released - not many bothered to read it and thus find themselves in todays situation. This is why it's so important to do your own research, don't believe what the CEO is stating - you need to have third party data to validate what a company claims.
http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1691-publichttp://www.msac.gov.au/internet/msac/publishing.nsf/Content/A7E579DCACE71672CA25874400129993/$File/1691%20Ratified%20PICO.pdf
"PASC noted that as PromarkerD is presented as a predictive test, this would estimate the differences in the proportion of people who will develop DKD over time according to different test results if clinical management changes in response to one or more of these different test results. Therefore any changes in
nominated and relevant clinical outcomes are predicated on ‘change in management’. The decision question was thus what changes of management will be associated with PromarkerD? Would (or should) those changes in management occur in the absence of PromarkerD if optimal patient management is
considered? PASC considered that it was unclear whether PromarkerD would change clinical decisions and result in changes in management that would lead to changes in clinical outcomes and costs. PASC noted that many of the possible changes in clinical management were relevant to all people with T2DM, such as managing HbA1c, blood pressure, lipids, and management of body weight. PASC noted that the application stated that SGLT2 inhibitors reduced PromarkerD scores and may prevent progression to DKD. PASC noted that the PBS restrictions for SGLT2 inhibitors may not allow this use.
PASC considered that evidence for how PromarkerD leads to change in clinical practice (clinical utility) and the impact of this on clinical outcomes has not been demonstrated and needs to be addressed."
(20min delay)