Diagnotic blood test to assess the risk of diabetic kidney disease moves closer to launch across Europe

Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ), a medical technology company headquartered in Perth, Australia, has announced the successful transfer of its PromarkerD technology to the laboratories of clinical diagnostics partner, Atturos, a UCD spin-out company based in UCD Conway Institute.

Currently in Europe, diabetes affects 58 million people, a number that is expected to rise to 67 million people by 2045 (International Diabetes Federation). An estimated one in three adults with diabetes already have chronic kidney disease, however, with early intervention it is possible to delay or prevent clinical symptoms of the disease.

PromarkerD is a diagnostic blood test that uses a unique protein ‘fingerprint’ to provide an early detection of the onset of diabetic kidney disease. Following the transfer of the technology to Atturos the PromarkerD test is now available as a mass spectrometry laboratory developed test (MS-LDT) to licence partners in the European market.

Proteomics has also announced the launch of PromarkerD in the first European country, Spain following the completion of a licensing deal with Patia Europe. Patia Europe is commercialising PromarkerD with the Laboratory Developed Test (LDT) being offered by Atturos.

The completion of the technology transfer coincides with the recent publication of the results of the PromarkerD clinical validation study in the Journal of Diabetes and its Complications. In the clinical study, PromarkerD correctly predicted 86% of otherwise healthy diabetic patients who went on to develop chronic kidney disease within four years.

Dr Richard Lipscombe, Managing Director, Proteomics International said, “We are excited to be able to offer the PromarkerD test in Europe for the first time and are working hard to give patients around the world the opportunity to know their diabetic kidney disease status. With dialysis treatment costing approximately €80,000 per year, PromarkerD has the potential to save patients and healthcare systems billions of dollars.”

Professor Stephen Pennington, CEO Atturos
Professor Stephen Pennington, UCD School of Medicine and Fellow, UCD Conway Institute is the founder and Chief Scientific Officer, Atturos.

Professor Pennington said, "It is a significant milestone for our two pioneering companies to be expanding the use of mass spectrometry for new clinical diagnostic tests, such as PromarkerD.”

“Atturos had applied the latest generation of analytical instrumentation (Agilent 6495 Triple Quadrupole LC/MS) to make the MS-LDT available and are now in the process of establishing the PromarkerD method into an integrated and automated sample workflow that includes the Agilent Bravo Automated Liquid Handling Platform.”

Atturos, working closely with Proteomics International's scientists, has undertaken a stringent validation process of the PromarkerD method and demonstrated data equivalence in 100 patient samples analysed in both laboratories.

The results of this successful "cross-over" study will be presented in the Precision Medicine and Clinical Proteomics section of the 18th Human Proteome Organization (HUPO) World Congress being held this week in Adelaide, Australia. Professor Pennington is the current President of HUPO.

Proteomics International is in discussions with tier-1 diagnostics and pharmaceutical companies, targeting the markets of Europe, Japan, India and the USA, to expand the global reach of PromarkerD.

The peer-reviewed work published in the Journal of Diabetes and its Complications was conducted in collaboration with the University of Western Australia Medical School. The paper entitled Validation of a protein biomarker test for predicting renal decline in type 2 diabetes: The Fremantle Diabetes Study Phase II, is available online via https://doi.org/10.1016/j.jdiacomp.2019.07.003.