Proteomics International (ASX:PIQ) has announced results from the clinical validation study showing its PromarkerD blood test can predict the onset of diabetic kidney disease (DKD) better than current measures. The findings were presented by Professor Tim Davis, from The University of Western Australia Medical School, at the American Diabetes Association's 77th Annual Scientific Sessions.
The study, undertaken as a joint collaboration between Proteomics International and The University of Western Australia, is the largest prospective clinical study on diabetic kidney disease and evaluated the clinical utility of PromarkerD with 792 patients.
According to the International Diabetes Federation, 415 million adults had diabetes in 2015. The US Center for Disease Control states that one in three adult diabetics have chronic kidney disease, or 138 million people today. Once detected, chronic kidney disease can be treated through medication and lifestyle changes to slow down the disease progression, and to prevent or delay the onset of kidney failure.
The International Diabetes Federation further predicts the number of diabetics will rise to 642 million by 2040. If unchecked, the number of adults with chronic kidney disease will increase by 76 million to 214 million.
The validation study, which assessed the performance of the prediction model in an independent population, confirms results from the original development study. Initial findings on the diagnostic performance of PromarkerD were published in the European Journal of Proteomics in March 2017.
In the four-year prospective study, the three protein marker (biomarker) blood test (PromarkerD) predicted 86 per cent of previously disease-free patients who went on to develop chronic kidney disease. In comparison to the development study, the results from the larger validation study showed slightly lower levels of predictive ability (development 95 per cent), however, it achieved a 10 per cent improvement in levels of false positives, said the company.
Professor Davis concluded, "The data support the use of the protein biomarker panel in conjunction with eGFR (estimated glomerular filtration rate) in patients with type 2 diabetes to monitor and predict their decline in kidney function."
"This large clinical study validates the important role of the PromarkerD test to effectively monitor patients with diabetes," said Dr Richard Lipscombe, managing director of Proteomics International. "Although patients may appear to be adequately controlled for the complications of diabetes, current tests do not reveal early symptoms of kidney disease, which can result in the need for dialysis or kidney transplant."
PromarkerD is a blood test that uses a protein 'fingerprint' to measure kidney disease in patients with diabetes. The test can both diagnose and predict disease.