Proteomics set to enter US healthcare market

Perth-based Proteomics International Laboratories is knocking on the door of a multi-billion-dollar market after signing a binding and exclusive letter of intent with one of the world’s largest medical diagnostic groups to licence its diabetic kidney disease test for the United States.

Under the letter’s terms, Sonic Healthcare USA would get an exclusive licence for use of PromarkerD in what is generally regarded as the world’s premier healthcare market.

PromarkerD is the world’s first predictive test for diabetic kidney disease.

Using only a simple blood test, it can predict the onset of diabetic kidney disease in type 2 diabetics up to four years before clinical symptoms appear.

About one in three diabetics has chronic kidney disease. Kidney function can decline significantly without any symptoms and because kidney damage is irreversible, early detection is critical.

Sonic Healthcare USA is a leading provider of laboratory and pathology services throughout America, with more than 8000 US-based employees.

It is a subsidiary of Sydney-based Sonic Healthcare, a specialist in laboratory medicine/pathology, radiology and medical services, with a market capitalisation of almost $17 billion and a global workforce of more than 38,000 people.

Proteomics describes the agreement with Sonic Healthcare USA as a pivotal event in PromarkerD’s rollout.

We have been working with Sonic Healthcare USA towards this goal for 15 months and now look forward to building upon this foundation and taking our world first predictive test for diabetic kidney disease into not only the US but also Europe where the test already has regulatory approval.

An estimated 32 million Americans suffer type 2 diabetes, with the total cost of diabetic kidney disease in that country estimated at US$130 billion a year.

One estimate predicts the prevalence of diabetes will increase to almost 55 million by 2030 when the total medical and societal bill will surpass US$622 billion annually.

Proteomics International specialises in the area of proteomics – the industrial-scale study of the structure and function of proteins.

The company’s patented PromarkerD test, a development of its Promarker technology platform, uses a simple blood test to detect a “fingerprint” of the early onset of diabetic kidney disease by measuring three protein biomarkers.

Proteomics cautions that PromarkerD’s market penetration in the United States cannot be predicted, adding it is impossible to quantify what financial impact the development will have on the company.

Commercial terms under the proposed licence have not been revealed.

However, the letter of intent it has signed with Sonic Healthcare USA does provide for “industry-standard terms for payment for PromarkerD”.

Stakeholder engagement drawn from a previous market access study for Proteomics estimates the price for PromarkerD test at about US$150. The standard industry royalty rate for such a test ranges from 5 to 15 per cent.

Under that scenario and considering the number of diabetics in America, any deal to licence PromarkerD would be a huge leap for Proteomics.

The company also will have been buoyed by a survey earlier this month of 400 doctors and endocrinologists in the US. More than three-quarters said they were very or extremely likely to order the PromarkerD test for their type 2 diabetes patients.

Professor David Klonoff, clinical professor of medicine at the University of California in San Francisco and an endocrinologist specialising in bioengineered solutions for people with diabetes says he is looking forward to the commercialisation of PromarkerD in the USA.

Klonoff says it is a significant step forward to bring the product to the US market because PromarkerD represents an effective laboratory tool that will enable clinicians to provide precision medicine diagnosis and prognosis for patients with type 2 diabetes who are at risk of renal failure.

Proteomics shares popped on the announcement, jumping 18.5 per cent to an intra-day high of $1.055.

Under the letter of intent, the two parties plan to sign an exclusive licence agreement by the end of the year, subject to certain milestone and events being met.

Lipscombe says he is optimistic that Proteomics has the right partner in Sonic Healthcare USA for the milestones to be achieved over the next two to five months.

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