A major clinical study involving 3,000 patients has validated ASX-listed Proteomics’ “PromarkerD” predictive test for diabetic kidney disease with the study confirming that PromarkerD has a high probability of predicting a clinical decline in kidney function up to four years in advance of it actually happening. With the major milestone achieved, Proteomics is now looking to commercialise the technology in the USA by way of an in-country partnership with a suitable counter-party.
The study showed that patients predicted by PromarkerD to be at high-risk of chronic kidney disease were 13.5 times more likely to develop the disease than those not identified by the test.
The company said PromarkerD is the world’s first, but most importantly, the only predictive test for diabetic kidney disease to have received European CE Mark registration. The now-validated diagnostic test enables a patient to begin effective treatment well in advance of the onset of serious symptoms.
Proteomics appears to be quickly building its brand as a pioneer in predictive diagnostics and bioanalytical services after its initial success with the PromarkerD technology.
According to the International Diabetes Federation, there are 463 million adults living with diabetes and currently 1 in 3 has diabetic kidney disease.
The findings of the latest multi-centre clinical study were presented over the weekend at the world’s leading diabetes conference, the 80th Scientific Sessions of the American Diabetes Association.
Proteomics has successfully expanded its PromarkerTM technology platform under Managing Director and founder, Dr Richard Lipscombe with the company’s business model centred on the commercialisation of diagnostic testing whilst offsetting its R&D cash burn through the provision of specialist third-party analytical services.
Dr Lipscombe said these latest results were far reaching for the commercial roll-out of the test because they substantiated the effectiveness of PromarkerD as a prognostic test for diabetic kidney disease in a globally recognised clinical cohort.
The ability to forward predict that a patient might be at risk from diabetic kidney disease means that doctors can take action to prevent patients from going on to costly dialysis and eventually requiring a kidney transplant.
Proteomics Managing Director, Dr Richard Lipscombe said: “PromarkerD works, it’s safe, and it can be run by accredited laboratories now as a laboratory developed test (LDT). This is really a green light for using this simple blood test globally.”
With the annual cost of diabetic kidney disease estimated at USD50 billion per year in the USA alone, Proteomics said this latest validation paves the way for possible future FDA approval of the test in the USA and complements the recent successful CE Mark registration of the new PromarkerD immunoassay in the European Union.
Diabetes represents a massive biotechnology market and if Proteomics can get a stable, accurate test into the market, it may well reap some long-term rewards from it.
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By Matt Birney
