Successful early diagnosis of diabetic kidney disease (DKD) delivers a win-win-win situation for the medical professionals who treat this disease, its sufferers and the cost base of any country’s health system. Doctors would gain access to speedier diagnosis, opening the way for them to deliver more efficacious treatment decisions that improve clinical outcomes for patients, inclusive of superior therapeutic interventions. At the same time, reducing or delaying the progression of DKD and consequently the incidence of dialysis and kidney transplant would result in significant cost savings for health care systems.

This is no pipedream. The Proteomics International (ASX:PIQ) PromarkerD predictive test for DKD has opened the door to improved treatment for the latter disease. It is a cost effective, easy-to-use blood test capable of predicting the onset of the disease in patients with diabetes and no existing DKD.

The company has just announced a further large step in PromarkerD’s journey to commercialisation, putting pen to paper on an exclusive licence agreement with Sonic Healthcare USA. It will see the latter group partner with Proteomics International to roll out the PromarkerD predictive test for DKD across the US. Under the agreement, Sonic Healthcare USA will be offering the test to physicians and healthcare systems through its client engagement teams across the US.

This country is potentially a massive market place – according to the International Diabetes Federation Diabetes Atlas (2021 IDF Diabetes Atlas), an estimated 32 million people, or 11% of the US population, live with type 2 diabetes.

Proteomics International Managing Director Dr. Richard Lipscombe said “We are delighted to enter the licence agreement with Sonic Healthcare USA. Both parties have been working diligently for many months towards the roll-out of PromarkerD in the USA.”

The prep work undertaken ahead of the agreement being signed saw:

• PromarkerD became a featured test on the Sonic Reference Laboratory (USA) test menu (in October 2022)
• A CPT PLA reimbursement code was approved (in January 2023)
• Proteomics’ PromarkerD Clinical Advisory Board being expanded to support the PromarkerD rollout in the US and beyond.

The licence with Sonic Healthcare USA is for five years, extendable by mutual agreement, and exclusive to the US (excluding Puerto Rico). The agreement also includes commercially agreed royalties based on sales of the test, timelines for milestone events to be achieved in relation to the commercialisation process, and provides terms for payment for PromarkerD test reagents.

Dr. Lipscombe additionally noted “The US is one of our key addressable markets and we expect this partnership to significantly increase the reach and adoption of PromarkerD through Sonic Healthcare USA’s physician and patient focused channels.”

The US agreement adds to Proteomics International’s existing international footprint. Less than two years ago, the company announced the signing of a United Kingdom (UK) distribution agreement with medical diagnostics company Apacor Limited. This arrangement was recently extended for an additional 5-year term. The PromarkerD test is now registered with the UK Medicines & Healthcare products Regulatory Agency, and the National Institute for Health and Care Excellence (NICE) has published advice on PromarkerD (in December 2022).

With the long term extension of the distribution agreement between Proteomics and Apacor completed, both are currently working towards the inclusion of PromarkerD in the NICE Guidelines and engaging with the NHS Supply Chain Tender process as part of the commercial rollout of the test in the UK.

And Proteomics’ PromarkerD technology is no ‘one trick pony’. The company has continued to advance several diagnostic research and development projects using the Promarker technology platform. These programs highlight the ‘blue sky’ packaged up in Proteomics’ medical technology, with it displaying broad applicability and the potential to produce multiple new diagnostic tests to address significant unmet medical needs.

For now, the exclusive licence agreement with Sonic Healthcare USA and the extended UK agreement with Apacor provide clear evidence that Proteomics International’s PromarkerD test is starting to penetrate key target markets.