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() has a world first announcing a predictive test for the diagnosis of diabetic kidney disease (DKD).
The test was developed and validated in a $2 million clinical study of 576 patients with diabetes followed between 2010 and 2014 in Western Australia.
The clinical study which is on-going found that 10% of the patients had a significant and rapid decline in kidney function over the four year study period.
Proteomics' PromarkerD correctly predicted 67% of these individuals.
There is currently no available test for predicting the onset of DKD.
The ability to accurately predict the onset of DKD via a simple blood test is ground breaking as it would provide a marker that could save health care systems billions of dollars.
This provides a large market opportunity for Proteomics as diabetes is the fastest growing health issue in the world today and is the largest cause of kidney disease.
In Australia the cost to the health system and in productivity loss attributed to diabetes is estimated at $10.3 billion annually.
Over 1.7 million Australians have chronic kidney disease 1.5 million are not aware they have the disease. While 35% of adults in the USA with diabetes have chronic kidney disease.
The commercial benefits to Proteomics in successfully commercialising the test are enormous. Pharmaceutical companies could market PromarkerD to identify at-risk patient groups and then to provide drugs to manage patients more effectively.
In this scenario it would provide Proteomics with substantial returns in the form of licensing fees and royalties.
The test was developed using PIQ's world-leading proprietary proteomics platform to measure specific biomarkers (biological signatures) in the blood of patients with diabetes to determine the likelihood of those patients contracting DKD.
Background
Specifically PromarkerD simultaneously measures a panel of 2-6 proteins to determine the patient's disease state.
Applying its mass spectrometry-based proteomics technology the Company has developed a deeper understanding of DKD beyond classical pathology by comparing the differences in the protein makeup of people with and without the disease.
The samples in the study were cross-validated with an established antibody-based technique broadly accepted by the US Food and Drug Administration (FDA) which showed there was excellent correlation between the two methods.
PromarkerD also has a diagnostic component (in addition to its predictive application) which utilises the biomarker panel to diagnose the early onset of DKD in a patient where current tests for kidney function fail to detect the disease.
Commercial potential
The International Diabetes Foundation estimates that 382 million people currently have diabetes worldwide and the number is expected to rise to 1 in 10 of the world's population by 2035.
According to the US Centre for Disease Control 35% of adults with diabetes have chronic kidney disease and 20% will end up with kidney failure which can only be treated by dialysis or a kidney transplant.
Extending PIQ's clinical study findings to the larger worldwide problem suggests that 25 million individuals of the 38 million at risk of significant and rapid decline in kidney function could be identified by PromarkerD. This would represent a massive potential market for the technology owner/developer and any licensing partner(s).
PromarkerD can be commercialised simply using today's standard pathology laboratory assay systems and in the future also via a specialist mass spectrometry test - which is likely to be common in next generation laboratories as technology is miniaturised.
Next steps
The Company is attending BIO 2015 the world's largest biotechnology conference in Philadelphia USA next week for discussions with major pharmaceutical companies.
PIQ will also continue to engage with global industry players for partnering and licensing opportunities to commercialise PromarkerD as a ground-breaking predictive test for the diagnosis of diabetic kidney disease.
Analysis
It is the next steps that begin to look very interesting for Proteomics as the diagnostic test will come under the gaze of major global players including "big pharma". If it isn't now - it soon will be.
There is significant ability for Proteomics to commercialise the predictive test given there is currently no available test for predicting the onset of DKD
With recent advances including a major contract win with the a2 Milk Company we calculate the current market cap of Proteomics of circa $10m to massively undervalue the company.
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