Proteomics International Laboratories Ltd’s (ASX: PIQ) European patent protection for the company’s PromarkerD predictive test has been expanded to include diagnosing all individuals who are prediabetic and asymptomatic for kidney disease.
Proteomics International’s original European patent was restricted to diabetic kidney disease only.
The new patent will now provide protection for the use of the PromarkerD test for any individuals with prediabetes, which is an at-risk category for kidney disease. The International Diabetes Federation estimates there are currently 537 million adults with diabetes, and an additional 541 million (10.6% of the world’s adult population) with prediabetes.
Prediabetes is a term used to describe people with impaired glucose tolerance (IGT) – it indicates a higher risk of developing type 2 diabetes and diabetes-related complications such as kidney disease.
The expanded patent coverage is an important addition to our PromarkerD intellectual property portfolio and provides an exciting opportunity to increase our addressable market in Europe, where we already have CE Mark registration,” Proteomics International managing director, Dr Richard Lipscombe, said.
“There is the potential for the PromarkerD test to be used to determine if a whole new group of people are at risk of developing kidney disease.”
The PromarkerD patent family already covers 63% of the world’s diabetics, where the test has been shown to correctly predict up to 86% of otherwise healthy diabetics who go on to develop diabetic kidney disease within four years.
Further clinical studies are needed to demonstrate that PromarkerD can be used to diagnose kidney disease beyond those with diabetes, however, there is already evidence that the biomarkers in the PromarkerD panel are important in chronic kidney disease more broadly.
Chronic Kidney Disease (CKD) is estimated to affect close to 100 million Europeans, with 300 million being at risk, and caused almost 130,000 deaths in Europe in 2019. Diabetes is the leading cause of kidney failure, accounting for 44% percent of new cases. CKD is estimated to cost Europe EUR140 billion per year, more than the annual healthcare costs for cancer or diabetes.