ASX-listed Proteomics International Laboratories has beefed up its clinical advisory board ahead of the rollout of its Promarker D predictive test for diabetic kidney disease in type 2 diabetes patients.
The company’s new advisory board members come from across the healthcare industry, with strong specialisations in primary-care diabetes education and management in the United States.
PromarkerD is a prognostic test that can predict future kidney function decline in patients living with type 2 diabetes, but who have no existing diabetic kidney disease. Proteomics says clinical studies published in leading journals show PromarkerD correctly predicted up to 86 per cent of otherwise healthy diabetics who went on to develop diabetic kidney disease within four years.
Diabetes care and education involves a broad range of healthcare professionals including GPs, endocrinologists, nephrologists, pharmacists, nurses, diabetes educators and dieticians.
The new members bring a wealth of knowledge in treating diabetes patients and they will be important advocates for the use of the PromarkerD test. We look forward to working with them as we bring PromarkerD to patients across the United States. Proteomics managing director Dr Richard Lipscombe
The new board members are Davida Kruger, a certified nurse practitioner in diabetes for more than 40 years at Henry Ford Health in Detroit, Michigan; Dr Joshua Neumiller a professor of pharmacotherapy at Washington State University and a clinical researcher at Providence Medical Research Centre; Dr Neil Skolnik a Professor of Family and Community Medicine at the Sidney Kimmel Medical College of Thomas Jefferson University and associate director of Family Medicine Residency program at Jefferson Health in Abington; and Hope Warshaw, a registered dietitian and a certified diabetes care and education specialist with more than 40 years of expertise in diabetes and care.
The board gains come on the back of the renewal of two key accreditations for Proteomics earlier this month, which significantly boosted the company’s plans for the global launch of its PromarkerD test.
The National Association of Testing Authorities of Australia gave the all clear for the renewal of Proteomics’ ISO 17025 accreditation, while the British Standards Institution renewed the company’s ISO 13485 certification.
ISO 13485 is designed to be used by organisations involved in the design, production, installation and servicing of medical devices and related services. The accreditation for laboratory testing enables cooperation with international laboratories and regulatory organisations. The certification also demonstrates the company’s standards are technically competent and ensures the delivery of accurate, valid and reliable results.
ISO 17025 is a globally-adopted certification that ensures safety and quality management of medical devices from design and development through to the manufacture and sale process. The accreditation is recognised as a primary standard for quality assurance in the European Union, Australia, Japan, Singapore and the US.
Proteomics argues PromarkerD can help prevent the need for renal replacement therapies such as dialysis and kidney transplant, potentially saving healthcare systems around the world billions of dollars a year.
The patented test system uses a simple blood test to detect a unique fingerprint of the early onset of diabetes by measuring three serum protein biomarkers, combined with routinely-available conventional clinical variables such as age. A cloud-based algorithm then integrates the results into a patient risk report.
In the US, an estimated 32 million people, or 11 per cent of the population, live with diabetes. According to the US Renal Data System, the total cost of diabetic kidney disease is US$130 billion (AU$196 billion) per year in the US alone.
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