– PromarkerD predicted 86% of disease-free patients who went on to develop chronic kidney disease within four years
– Largest prospective clinical study on diabetic kidney disease in the community, evaluating 792 patients over 4yr period
– Presented at American Diabetes Association’s 77th Annual Scientific Sessions, 9-13th June in San Diego
SAN DIEGO, CA — Proteomics International Laboratories Ltd (‘PILL’, ASX: PIQ), a global leader in applying proteomics to MedTech, has announced results from the clinical validation study showing that its PromarkerD blood test can predict the onset of diabetic kidney disease (DKD) better than any current measure.
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 (ADA), 9-13th June, in San Diego, California. (ADA Abstract #2017-LB-7091-Diabetes)
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 in the community and evaluated the clinical utility of PromarkerD with 792 patients.
In March, Frost & Sullivan identified PromarkerD as the world’s leading test for diabetic kidney disease, and the new results confirm PromarkerD predicts rapid decline in kidney function in type 2 diabetes, across clinically significant definitions of disease, independently of recognised clinical risk factors.
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, which, if unchecked, will increase the number of adults with chronic kidney disease by 76 million to 214 million. The current cost of dialysis is estimated at $100,000 per person per year.
The validation study (assessing the performance of the prediction model in an independent population) confirms results from the original development study, also completed in collaboration with Professor Davis. 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% of previously disease-free patients who went on to develop chronic kidney disease (Sensitivity 86%, Specificity 78%, AUC 0.88). In comparison to the development study, the results from the larger validation study showed slightly lower levels of predictive ability (development 95%), however, it achieved a 10% improvement in levels of false positives.
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.”
The annual ADA Scientific Sessions are the world’s largest and most prominent meeting of diabetes experts, attracting more than 13,000 delegates. The results were reported in the Late-breaking Abstracts section of the conference, titled “Novel Circulating Biomarkers Predicting Rapidly Declining Renal Function in Type 2 Diabetes: The Fremantle Diabetes Study”. PILL’s head of business development Chuck Morrison is also attending the event.