OwlvsFox (was also previously invested) found the publicly...

OwlvsFox (was also previously invested) found the publicly available MSAC report and shared it with me this morning.
After reading the MSAC report, I am no longer a fan and am struggling to understand how some on here still believe the fundamentals are solid.
Anyone that wants a real insight into what they are investing in needs to read every page of the report, it's seriously concerning and makes me question allot of the spin Richard and co have been telling investors for the last few years.

The summary in itself clearly indicates why no progress has been made with commercialisation, the simple answer is - more studies are needed.

After considering the strength of the available evidence in relation to comparative safety, clinical
effectiveness, cost-effectiveness and total cost, MSAC did not support public funding of
PromarkerD testing in patients with type 2 diabetes to determine the risk of developing DKD.
MSAC considered that the clinical utility of the test was uncertain because the evidence that the
test would change clinical management was based on a survey of intent, not actual evidence of
change, was at high risk of bias, and the test had a low positive predictive value (PPV). MSAC also
had concerns about the evidence for the prognostic value of the test, given its high risk of bias;
and the safety of the test, given its low PPV and the lack of detail provided on the proprietary
“black box” algorithm. MSAC considered the cost-effectiveness was uncertain as the model used
for the economic evaluation did not include the test outcomes to allow comparisons with the
current clinical approach. In addition, MSAC considered the economic modelling and financial
estimates were uncertain and contained errors and omissions.MSAC also considered the
proposed MBS fee was high and unjustified, and the uncertainty regarding test uptake also
impacted the financial estimates.

MSAC noted that, in the pre-MSAC response, the applicant agreed with ESC that the eligible
population should be restricted to patients who are currently in the low-risk category (i.e. those
with eGFR ≥60 mL/min/1.73 m2 and/or uACR <2.5 mg/mmol if male or <3.5 mg/mmol if
female). MSAC noted the Department’s proposal that the thresholds for the uACR levels that
confer eligibility should be detailed in an explanatory note. MSAC considered that, because of
these changes to the proposed population, the economic model would need to be revisited.
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.

MSAC considered PromarkerD to be an additional test to usual care, not a replacement, as patients with diabetes should always be screened with
uACR at least once a year.

PPV and NPV – PPV appears to be low (30.4% from Peters et al. 2019 and 58.8% from
Peters et al. 2020, compared with NPV of 98.1% and 86.4%). As noted previously, in the
pre-MSAC response, the applicant states that the strength of PromarkerD is its ability to
rule out patients at low risk (i.e. a high NPV) rather than the PPV.
• ability to predict decline in eGFR (greater than 30%) over four years – this was found to
be poor.


For change in management, MSAC noted that the evidence only consisted of a survey of intent,
and not actual evidence of change. MSAC noted the pre-MSAC response that stated that realworld evidence of change in management could not be undertaken as it would be unethical.
MSAC noted that the results of the American survey by Fusfeld et al. (2022)3, reported in the
ADAR, showed that PromarkerD was not considered to be the most important factor in making a
decision for prescribing or replacing therapy.

Source: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A7E579DCACE71672CA25874400129993/$File/1691%20Final%20PSD-Nov2022_Redacted.pdf

Plenty more in the PDF - please take the time to read it. I will not be buying back in, I am not trying to spread FUD - just sharing what I would like to be shared with me if I was invested and unaware of the specifics. I feel Richard and Co have not been fully transparent with how PromarkerD is being received by regulatory agencies.

Between Owl & I - we suspect SHL deal is so they can do real-world studies as that is what's needed to get all the regulatory approvals.
Patent expires in 2031, not many years left if they now need to more studies.