Proteomics International Laboratories has strengthened its fight against kidney disease with the identification of a diabetes drug that has boosted the prospects of its PromarkerD predictive test.
A new study, published in the esteemed peer-reviewed Journal of Clinical Medicine, found that patients who took “canagliflozin” showed a significant reduction in risk scores through the company’s PromarkerD predictive test for diabetic kidney disease.
The research also showed that the patients who had been identified as being at high risk of kidney disease at the start of the study had received the greatest benefit.
The study was a collaboration between Proteomics and the pharmaceutical arm of Johnson & Johnson, Janssen Research and Development. Researchers were studying the link between canagliflozin, which is an approved diabetes therapy with additional kidney and cardio-protective benefits, and changes in PromarkerD scores for people living with type 2 diabetes.
The three-year study involving more than 2000 participants found that the risk scores were lowered for those who took the medication, while average scores rose for those who took a placebo. The results have complemented the company’s earlier test outcomes, which were presented at the Australasian Diabetes Conference in 2021.
Management believes the new publication demonstrates that drugs such as canagliflozin can lower PromarkerD risk scores and have the potential to treat at-risk patients identified by the test. It says it further highlights the key role Promarker D can have in fighting kidney disease.
The findings illustrate the benefits of using PromarkerD testing - it’s exciting that we can identify patients who are asymptomatic for diabetic kidney disease but still at high risk of developing the disease and that canagliflozin significantly lowers their risk of developing diabetic kidney disease. It’s an elegant example of using precision medicine to enable early intervention and slow or stop the onset of disease.
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. Proteomics International Laboratories managing director Dr Richard Lipscombe
Just last month, Proteomics beefed up its clinical advisory board ahead of the rollout of its PromarkerD test. The new advisory board members come from across the healthcare industry, with strong specialisations in primary-care diabetes education and management in the United States.
The board gains followed the renewal of two key accreditations for Proteomics earlier in April, which significantly boosted the company’s plans for the global launch of PromarkerD. 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 that 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.
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.
Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation and between 2000 and 2019, there was a three per cent increase in diabetes mortality rates by age.
In 2019, diabetes and kidney disease due to diabetes caused an estimated two million deaths worldwide.
However, the disease can be treated and its consequences avoided or delayed with diet, physical activity, medication and regular screening and treatment for complications. It means a test such as Promarker D could potentially help millions of people achieve greater health outcomes, let alone save millions of lives.
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