Medical diagnostics business Proteomics International (ASX: PIQ) has reported the publication of a “landmark” study showing that its PromarkerD test used to predict future kidney function decline in patients with type 2 diabetes significantly outperforms current standard-of-care tests.
Management noted that the outcomes bring to light the potential for PromarkerD to revolutionise diabetic kidney disease (DKD) risk assessment and management, improve patient outcomes, and reduce healthcare costs.
Superior predictive accuracy
The community-based study followed 857 adults with type 2 diabetes over four years, comparing PromarkerD’s predictive accuracy against conventional tests.
The study found that participants classified as high risk by PromarkerD had significantly higher odds of experiencing kidney function decline.
More specifically, PromarkerD identified 84 per cent of individuals with normal kidney function at a baseline level who later developed significant kidney decline. Management believes these cases would have been missed by standard classification methods.
The study also showcased PromarkerD’s ability to accurately categorise patients at low risk of developing DKD whilst reducing false positives compared to standard tests. These findings point to the test’s potential to transform DKD management by enabling earlier and more accurate risk assessment.
Findings from this study were published in a special edition of the peer-reviewed journal known as ‘Diagnostics’. The results build on data first presented by the company at the American Society of Nephrology Kidney Week Conference in November 2021.
Proteomics managing director, Dr Richard Lipscombe, commented:
“This peer-reviewed comparison against standard of care is critical in proving the power of PromarkerD to the medical community. As we acknowledge Kidney Health month in the US, we want to provide healthcare professionals with the best tools available to combat this debilitating disease.”
Globally significant disease
According to Proteomics, diabetes affects more than 537 million people globally with chronic kidney disease (CKD) representing a major complication that can lead to severe health outcomes and increased mortality.
In particular, diabetes has emerged as the largest single cause of end-stage renal disease leading to dialysis or kidney transplants in developed and developing countries.
Based on data from the American Society of Nephrology, CKD is largely asymptomatic in its early stages which can cause many patients to suffer silently prior to diagnosis. In turn, the lack of early detection can result in fatalities since kidney dysfunction that lasts longer than three months is often irreparable.
Commercialisation push
Proteomics recently opened its certified Reference Laboratory in California to service the US market with PromarkerD. The test will initially be available through a direct-to-consumer go-to-market route as a prelude to out-licensing to major industry players in the diagnostics sector.
The company estimates that 32 million adults in the US have diabetes with DKD costing the nation about US$130 billion per year.
Proteomics is also gearing up to launch PromarkerD in Australia.