Proteomics International’s (ASX: PIQ) PromarkerD blood test has proven to be a step up from current tests in detecting patients at risk of diabetes-related kidney disease in a Perth-based study just published in an international peer-reviewed medical journal.
The company’s flagship PromarkerD biomarker-based diagnostic platform significantly outperformed the two standard methods of detecting a decline in kidney function in a community-based study of 857 adults diagnosed with type 2 diabetes.
The landmark results were published in a special edition of the journal Diagnostics and provide another feather in Proteomics’ cap as it moves towards a commercial roll-out of the device in the United States and Australia.
In a four-year study, PromarkerD was compared to one or both current standard diagnostic markers for kidney decline – an eGFR test which measures how well the kidneys are working or an uACR screen which tests for the protein albumin in the urine. Properly functioning kidneys do not secrete albumin into urine.
PromarkerD outperformed standard tests across the board, delivering higher predictive accuracy for key clinical markers. It flagged more high-risk and moderate-risk patients who later developed kidney disease including those the current tests completely missed.
The study also found patients identified by PromarkerD as being at high risk of developing kidney disease within four years were 21 times more likely to develop the disease than those labelled low risk. In stark contrast, the standard diagnostic procedures only showed a slight increase in risk of 1.28 times.
Current tests remain useful in predicting diabetes-related kidney decline but have limited accuracy and can be influenced by factors such as exercise, a patient’s muscle mass, fluid intake, infections or medication changes.
The company says ProMarkerD’s high predictive rate would be a game-changer for earlier intervention, better patient outcomes and lower healthcare costs of chronic kidney disease, which is largely without symptoms in its early stages.
New-generation drug treatments which can reduce kidney disease progression make early detection of at-risk patients even more important.
Proteomics last month opened the doors to a clinical laboratory in California to capture what it sees as a huge commercial opportunity for its diagnostic test. The laboratory was certified by State officials to offer a range of novel blood tests direct to patients, marking Proteomics’ formal entry into a massive US diagnostic market.
The new modular facility is a perfect twin of the company’s Perth operations, which should help the company deliver a smooth roll-out of its diagnostic platform and allow for future expansion as demand surges.
Proteomics is also gearing up for an Australian launch of PromarkerD, initially targeting the direct-to-consumer segment before locking in partnership deals with major diagnostics providers.
Precision diagnostics is one of the world’s most lucrative up-and-coming healthcare sectors and is projected to be worth more than US$100 billion by 2030.
Diabetes affects more than 537 million people worldwide and up to 50 per cent of those with type 2 disease will develop chronic kidney disease. Diabetes-related detection is likely to play a major part in the growth of the healthcare market.
PromarkerD’s potential to reduce the clinical and financial burden on patients and the broader healthcare systems by improving the early detection of a chronic illness is likely to be extremely well received by policymakers and insurers.
As the world rapidly moves towards proactive disease management, Proteomics’ technology seems to bear all the hallmarks of a future commercial success and represents a potential win-win-win for the company, the medical industry and sufferers.
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