Medical technology company Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) has signed the first licence agreement for its world-leading PromarkerD predictive test for diabetic kidney disease in the United States, creating a partnership with US-based precision medicine and diagnostic services laboratory PrismHealthDx, Inc. (PHDx).
Proteomics International has granted PHDx, head-quartered in Austin, Texas, a licence for the clinical market in the USA to make PromarkerD available to the more than 30 million Americans living with diabetes. Commercial details for the licensing agreement remain confidential.
The USA has one of the highest rates of diabetes in the world and is by far the biggest spending country on diabetes-related healthcare. Kidney disease is responsible for 48,000 deaths a year in the USA—the ninth leading cause of death—and related healthcare spending tops US$50 billion a year. Dialysis treatment alone costs US$72,000 per person per year, according to the US Renal Data System. Diabetes accounts for 44 per cent of chronic kidney disease cases in the USA.
Proteomics International Managing Director Dr Richard Lipscombe said PromarkerD was a major weapon in the battle against the diabetes epidemic; and that the breakthrough deal for PromarkerD in the USA is important because it paves the way for other licensing contracts.
“Regular testing and early diagnosis of diabetic kidney disease with PromarkerD can help millions of people avoid costly and invasive dialysis treatment or a kidney transplant,” Dr Lipscombe said.
“It is great to see PromarkerD launching in the world's largest healthcare market as we further negotiations to commercialise the test in other countries including Mexico, Japan, Australia, China and Europe.”
Under the licence agreement PHDx will develop and commercialise the PromarkerD mass spectrometry “Laboratory Developed Test” (LDT) in its specialist certified laboratories. The LDT permits fast adoption of a new test in advanced markets. PromarkerD is a simple blood test that uses a unique protein ‘fingerprint’ to detect signs of disease.
PromarkerD is the first test able to predict the onset of diabetic kidney disease, warning of a decline in kidney function up to four years in advance. The test can also diagnose diabetic kidney disease better than the current gold standard tests. PromarkerD has the potential to spare millions of people from future dialysis costs, and save the US healthcare system hundreds of billions of dollars.
For every million people living with diabetes, 10 per cent—or 100,000 people—are expected to suffer a rapid decline in kidney function within the next four years. The PromarkerD test is able to predict this decline in kidney function in 86 per cent of cases. This means that if every one of the 30 million Americans with diabetes took the test it would potentially identify 2.6 million of the 3 million people on the path to kidney disease. Those identified would require systematic retesting to verify effectiveness of treatments. Another 84 million American adults—more than 1 out of 3—have prediabetes, a precursor to diabetes, and may also benefit from taking the PromarkerD test.
“We are very excited to launch this product nationally across the USA,” Jim Canfield, President and CEO of PHDx shared.
“This revolutionary technology will complement PHDx's existing portfolio to create the leading diabetes test offering in the country.
"It will save lives and improve the quality of life for diabetes sufferers, all while reducing the cost to the healthcare system.”