Perth biotech goes global with pioneering kidney disease test

April 2019

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In a world-first, biotech company Proteomics International has discovered a predictive diagnostic test to help manage one of the complications of diabetes and a leading cause of death — diabetic kidney disease

The discovery by Perth-based Proteomics International (Proteomics) could have a major global impact. With 425 million sufferers worldwide, diabetes is a growing global health challenge. Today, one in three sufferers has already developed diabetic kidney disease (DKD), making it the 16th leading cause of death in the United States.

With its PromarkerD test, Proteomics has taken a giant stride in clinical diagnostics – creating a diagnostic tool that can identify a patient’s risk of developing DKD before they display clinical symptoms. Now, Austrade is helping Proteomics navigate growth into global markets with one-on-one introductions, advice and connections to potential licensees.

Fighting diabetic kidney disease

Founded in Perth in 2001, Proteomics is a recognised global leader in the field of proteomics – the study of proteins produced by living organisms. With a team of 30 people, it operates from purpose-built laboratories at the Harry Perkins Institute of Medical Research.

During the past decade, Proteomics has focussed part of its clinical research effort on improving the diagnosis for DKD. According to Proteomics International Managing Director, Dr Richard Lipscombe, the principal clinical challenge is that the early stages of DKD are usually asymptomatic.

‘Although patients may appear to be adequately controlled for the complications of diabetes, current tests do not reveal early symptoms of kidney disease,’ he says.

The prize of discovering a predictive diagnostic test is therefore immense and valuable. Full-blown DKD is incurable and the cost of dialysis can reach approximately A$79,000 per patient per year, according to Kidney Health Australia. In many countries, however, the cost and logistics of dialysis make DKD effectively untreatable.

‘Regular testing and early diagnosis of diabetic kidney disease could help millions of people avoid costly and invasive dialysis treatment or a kidney transplant,’ says Lipscombe.

A world-first for Australian biopharma

Starting in 2008, Proteomics began research into biomarkers for DKD. This is now being commercialised as a new predictive test for DKD called PromarkerD.

‘Clinical testing involved 792 patients with Type-2 diabetes,’ says Dr Lipscombe. ‘The PromarkerD test excelled, predicting 86 per cent of previously disease-free patients who went on to develop DKD within four years. This large clinical study validates the important role of the PromarkerD test to effectively monitor patients with diabetes.’

The results constitute a major scientific advance. The intellectual property behind the PromarkerD test has been patented in major jurisdictions around the globe, including the US, Japan, Europe and China.

A report of the clinical studies and results was presented at the Annual Scientific Session of the American Diabetes Association, and published in the prestigious, peer-reviewed journal, Diabetes Care.

The global research house, Frost & Sullivan, rated Proteomics’ PromarkerD as the world’s leading diagnostic test for DKD.

The export opportunity

By mid-2017, Proteomics’ principal challenge was how to quickly commercialise its DKD test in global markets. The opportunity is vast. The company estimates the total global cost of treating DKD at US$ 100 billion per year.

Proteomics’ strategy to commercialise PromarkerD is to work with partners who can provide the test under licence. This means identifying in-country clinical laboratories who can provide the PromarkerD test in their local markets.

In August 2016, Proteomics signed its first licensing agreement with a local health services company, Macrotech Farmaceutica, which has recently launched the PromarkerD test in the Dominican Republic. This was followed by a licensing deal with Patia Biopharma to launch the test in the Mexico. In November 2018, Proteomics signed a licensing agreement with Patia Europe to launch PromarkerD in Spain.

Help from Austrade around the world

Austrade is helping Proteomics by providing multiple introductions around the world. Austrade’s objective is to help Proteomics connect with potential licensees and navigate stakeholders in overseas health-related government agencies.

In India, Austrade provided insights into the local market and introductions to pharmaceutical companies. Austrade supported and attended capability roadshow seminars in major Indian cities, as Proteomics engaged with biopharma service providers across India.

In Mexico, Austrade has provided advice on how Proteomics can communicate the potential impact of its new DKD test with key government and industry stakeholders, and thereby accelerate demand for its service.

‘Austrade has introduced us to connections in overseas markets,’ says Lipscombe. ‘We want to provide PromarkerD to diabetes sufferers around the world, and we see Austrade as being able to help us achieve that.’

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