Proteomics’ predictive diabetes test to be sold in US and could soon be coming to Australia

Medical technology company Proteomics International Laboratories (ASX: PIQ) has announced a significant commercial development this morning with the news that its novel predictive diagnostics PromarkerD diabetes-detection test would be marketed and distributed in the United States.

The US is currently regarded as the largest market for diabetes in the world with over 30 million people (around 10% of the population) currently suffering from various types of diabetes.

Proteomics has agreed to a deal with Texas-based company PHDx, for the company to market its PromarkerD across the US under a national licence agreement.

In Australia, Proteomics is collaborating with Dimerix (ASX: DXB) as part of a joint investigation into detecting and treating kidney disease.

PromarkerD is a simple blood test that uses a unique “protein fingerprint” to detect signs of kidney malfunction. PHDx will develop and commercialise the PromarkerD mass spectrometry ‘Laboratory Developed Test’ (LDT) at its specialist certified laboratories with Proteomics saying that first sales are anticipated to occur in “four to six months”.

The medical technology company also said that it expects to receive royalties on all tests sold which could potentially reach into the millions given that PromarkerD’s predictive capabilities.

However, despite the positive nature of the news and the prospect of US-based clinics offering the test to millions of people, the company did say that given the commercially sensitive nature of the license agreement, it has decided to keep details of the agreement confidential for now.

Predictive capability

According to Proteomics, PromarkerD is the first clinical test that’s able to predict the onset of diabetic kidney disease and provide forewarning 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.”

Medical research indicates that 10% of people living with diabetes are expected to suffer a rapid decline in kidney function within four years. The PromarkerD test can predict this decline in kidney function in 86% of cases according to Proteomics, with the company asserting 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.”

“We are very excited to launch this product nationally across the USA. 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,” said Jim Canfield, president and CEO of PHDx.

The prospect of PromarkerD being offered in the US has the potential to deliver both a significant boost to the US healthcare system, but also, could create significant commercial returns for Proteomics. PromarkerD has the potential to spare millions of people from future dialysis costs and save the US healthcare system hundreds of billions of dollars if adopted in sufficient quantities.

“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,” said Dr Richard Lipscombe, managing director of Proteomics International.

With a commercial licence deal now signed with PHDx, state-wide distribution across the US could accelerate a wider distribution network globally, according to Proteomics.

“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,” said Dr Lipscombe.

In early trading this morning, Proteomics shares were up 5% at A$0.24 per share.