A new study shows biotech company Proteomics International Laboratories’ proven diagnostic test for diabetic kidney disease, PromarkerD, has the potential to predict late-stage renal decline, a condition where the kidneys lose the ability to remove waste and rebalance fluids.
The test already has the ability to predict the onset of the condition up to four years in advance, however the collaborative study with Janssen Research and Development has extended the potential use of the test to predict further decline in renal function among people who already have kidney disease.
The commonly used tests today have limited ability to predict chronic kidney disease progression.
The value in the latest development comes as predicting late-stage diabetic kidney disease can assist in the application of treatment programs aimed at delaying dialysis and renal failure for patients.
Proteomics’ positive results were presented overnight at the American Diabetes Association’s annual Scientific Sessions conference, an event that typically attracts more than 10,000 delegates.
The findings have the potential to further broaden the company’s target market, encompassing 32 million adults already with diabetes in the United States.
A third of people with type 2 diabetes have chronic kidney disease, the leading cause of end-stage renal disease.
Type 2 diabetes for which PromarkerD is based, accounts for about 85 per cent of all diabetes.
In 2015, the International Diabetes Federation estimated that one in 11 adults had diabetes and the condition swallowed a sizeable 12 per cent of global healthcare expenditure, totalling US$637 billion.
By 2040, the federation estimates one in 10 adults will have diabetes and diabetes-related health expenditure will exceed US$802 billion.
This exploratory data is promising and indicates the use of PromarkerD may be expanded to include people with existing kidney disease…… The results also suggested further studies were warranted to explore whether PromarkerD could predict additional cardiovascular outcomes, such as heart failure and stroke.
The findings come from analysis of the completed Canagliflozin cardiovascular assessment study, or ‘CANVAS’, as part of the ongoing collaboration between Proteomics and multinational medical company Johnson and Johnson’s subsidiary Janssen Research and Development.
CANVAS was aimed to test the efficacy of canagliflozin, a medication designed to lower blood sugar levels in people with type 2 diabetes. The trial found the drug was superior to the placebo in preventing cardiovascular events.
The study of PromarkerD was based on analysis of the 3525 people with type 2 diabetes participating in the completed CANVAS trial.
The key findings were moderate and high-risk PromarkerD scores were increasingly predictive for adverse renal and cardio outcomes. Additionally, the test’s ability to significantly predict late-stage outcomes remained after adjusting for other clinical risk factors, including existing kidney function, age, diabetes duration and blood pressure.
Given Diabetes Australia labels diabetes as the fastest growing chronic condition in Australia —increasing at a faster rate than even heart disease and cancer — the upside for both public health and Proteomics is potentially substantial.
The medical technology company also has other diagnostic tests in the pipeline, including the detection of endometriosis, asthma and chronic obstructive pulmonary disease and oesophageal cancer.
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