Proteomics awarded vital CE Mark registration for PromarkerD
Proteomics International Laboratories Ltd (ASX:PIQ), a pioneer in predictive diagnostics, has secured CE Mark registration for its PromarkerD Immunoassay kit as an IVD medical device (in vitro diagnostic).
PromarkerD (IA) forms part of the PromarkerD test system which is the only test available in the Europe Union for predicting the onset of diabetic kidney disease (DKD).
The PromarkerD Immunoassay is the high-throughput version of the already CE Marked PromarkerD (MS) Mass Spectrometry test system.
This will allow a greater number of prospective laboratories to process much higher numbers of samples at a more cost effective rate.
This is a key market for Proteomics as the company’s business model is centred on the commercialisation of its world-leading test for diabetic kidney disease, PromarkerD.
The group offsets the cash burn from research and development and product development through provision of specialist analytical services, whilst using its proprietary Promarker technology platform to create a pipeline of novel diagnostic tests.
Low-cost test provides early warning
PromarkerD was registered for use in the EU as part of the company’s program of regulatory and reimbursement registrations.
The PromarkerD test system assesses the risk of DKD in patients with type 2 diabetes.
The World Health Organisation estimates the European region is home to 60 million adults with diabetes, and currently one in three have chronic kidney disease.
Chronic kidney disease is one of the major complications arising from diabetes and if unchecked can lead to dialysis or kidney transplant.
PromarkerD is a simple, low-cost blood test that uses a unique protein ‘fingerprint’ to detect the onset of disease up to four years before clinical symptoms appear.
The early detection and prevention or treatment of DKD is a major focus of both global pharmaceutical companies and government health departments.
CE Mark registration provides assurance to licensing partners
The CE Mark is a significant commercialisation step for Proteomics International, providing assurance to potential licensing partners and consumers that the product has been developed and manufactured to meet EU safety, health and environmental protection requirements.
Dr Richard Lipscombe, managing director of Proteomics International highlighted the benefits of high-volume testing in saying, "The CE Mark is another important milestone for PromarkerD as we move forward with new deals in the region.
‘’With CE Mark the immunoassay offers a higher-throughput option for testing laboratories who want access to our ground-breaking test for predicting diabetic kidney disease — one that could enable earlier therapeutic intervention to minimise the effect of this crippling disease."
Achieving CE Mark registration for the PromarkerD (IA) provides a strong foundation for PromarkerD to receive US FDA approval.
Proteomics International intends to lodge the US FDA application in mid-year 2020.
Given PromarkerD can aid clinical decision making by identifying at-risk individuals for earlier therapeutic intervention to help to minimise the effect of the disease, potentially saving healthcare systems billions of dollars there are definite incentives for other countries to support its introduction.