Sonic, Proteomics team up to predict diabetic kidney disease in the US

Pathology giant Sonic Healthcare and life sciences company Proteomics partner to develop a world-first for people with kidney disease.

Proteomics has developed a blood test that can predict which patients with diabetes will progress to have diabetic kidney disease.

Australian life sciences company Proteomics has extended its agreement with pathology giant Sonic Healthcare to launch its world-first predictive test for diabetic kidney disease in the US.

Proteomics, which is listed on the ASX with a market value of $123m, announced the partnership with Sonic last August following 15 months of negotiations.

On Thursday the company extended the term of its letter of intent (LOI) with Sonic until January 31 this year, saying the extra month would enable “both parties the necessary time to finalise the agreement” for the PromarkerD test.

“Importantly a number of key milestones have already been achieved under the LOI,” Proteomics said in an announcement to the ASX.

“Proteomics International notes that the test has been optimised for a high-throughput environment and PromarkerD became a featured test on the Sonic Reference Laboratory (USA) test menu in October.”

The company said the American Medical Association has also approved and published a dedicated reimbursement code for PromarkerD.

PromarkerD is a newly developed blood test that can predict which patients with diabetes will progress to have diabetic kidney disease and which people with normal kidney function, as measured by conventional tests, are at risk of developing the disease.

Proteomics said its test, which had been validated, represented a breakthrough in the diagnosis and treatment of the disease. The company said the benefits to it successfully commercialising the test were enormous.

It is estimated about 32 million people, or 11 per cent of the population, in the US live with type 2 diabetes. Diabetic kidney disease is a serious complication arising from diabetes which if unchecked can lead to dialysis or kidney transplant and costs about $US130bn a treat in the US alone.

In the past six months, Proteomics shares have surged 21.6 per cent to $1.04. Meanwhile Sonic has sagged 9.6 per cent to $30.30 as demand for government-funded Covid-19 tests plummets.

Proteomics managing director Richard Lipscombe said the partnership with Sonic’s US division was a “pivotal point” in the global rollout of PromarkerD.

“The US is the world‘s premier healthcare market and we are delighted to be working with Sonic Healthcare USA, one of the world’s leading diagnostic companies. It is rewarding for us to see their appreciation for what PromarkerD can offer diabetes patients,” Dr Lipscombe said when he announced the partnership last August.

“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.”

The PromarkerD test will be launched in the US via Sonic Healthcare CLIA certified clinical laboratories.

David Klonoff - a clinical professor of medicine at the University of California and an endocrinologist specialising in bioengineered solutions for people with diabetes - said he was looking forward to the commercialisation of the PromarkerD assay in the US.

“It is a significant step forward to bring this product to the US market now since 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,” Professor Klonoff said.