Australian medtech developer Proteomics International Laboratories (PILL, ASX: PIQ) has reached a landmark milestone having secured CE Mark certification for commericalisation of their in vitro diagnostic medical device in Europe, which can predict the early onset of diabetic kidney disease.
The device, PromarkerD, takes a blood test which then creates a unique protein fingerprint which can detect bio-markers that are precursors of diabetic kidney disease up to four years before the individuals starts showing clinical symptoms.
“The CE Mark is another important milestone for PromarkerD as we move forward with new deals in the region,” said Managing Director of Proteomics International, Dr Richard Lipscombe.
“CE Mark registration reflects the strength of the clinical and technical data that we have collected in developing our ground-breaking test that could help save healthcare systems billions of dollars”.
With the certification, Proteomics will commence commercialisation of PromarkerD through the European Union with the company anticipating the regulatory approval to lay the foundation for its other projects in development, specialising in proteomics – the large scale study, structure and function of proteins.
According to the World Health Organisation, there are more than 60 million adults in Europe with diabetes, of which 1 in 3 have chronic kidney disease.
Globally, there are 425 million diabetes sufferers and through the PromarkerD predictive test, Proteomics International hope to assist doctors in prescribing early treatment to stop the onset of kidney disease before the need for dialysis or transplants.
The next most advanced project being targeted by Proteomic’s protein fingerprint aims to identify Giardia (gastro infection).