Proteomics says testing of its “PromarkerD” predictive test kit for kidney disease shows it to be better than current standard of care solutions in predicting future decline in kidney function in diabetics. In a recent study, PromarkerD correctly identified 84 per cent of patients with normal kidney function who subsequently went on to experience kidney function decline that would have otherwise been overlooked by existing solutions.
The study was a continuation of a previous analysis of PromarkerD’s ability to predict Diabetic Kidney Disease. It involved a retrospective investigation of more than 850 patients with type two diabetes from the company’s past Phase II Fremantle Diabetes Study.
According to the company results of the retrospective evaluation show PromarkerD outperformed current standard of care tests in predicting the onset of Diabetic Kidney Disease during a four-year follow-up period.
The study concluded that the 84 per cent of patients who experienced a decline in kidney function would have been missed by the “eGFR” and “ACR” tests – the current gold standard of care imposed under the global Kidney Disease Improving Clinical Outcomes, or “KDICO” guidelines for risk classification.
Notably, PromarkerD returned a higher predictive performance than the eGFR test, the ACR test and both eGFR and ACR combined.
It also accurately identified 89 per cent of patients with abnormal kidney function who declined even further during the course of the study.
Management says the study provides a key body of evidence on PromarkerD’s predictive ability that can be submitted to regulatory bodies around the world.
The test measures the level of three plasma biomarkers in the blood that are combined with clinical data to generate a PromarkerD score, categorised as low, moderate or high risk.
The study found patients classified by PromarkerD as high risk were 21 times more likely to develop diabetic kidney disease within four years than those classed as low risk. Patients categorised as moderate risk were eight times more likely than low risk patients to develop the disease.
PromarkerD also showed an excellent “rule-out” rate for classifying patients at low risk of developing Diabetic Kidney Disease across all KDICO categories. It also demonstrated significantly less false positive results in the study than current standard of care tests.
PromarkerD gives doctors the data they need to support early introduction of preventive medications to slow the progression of DKD in high-risk patients, closer monitoring of risk factors in moderate-risk patients, and rationalised treatment options in low-risk patients.
Proteomics is now set to spread the word on the study findings to more than 10,000 industry attendees at ASN Kidney Week – the largest nephrology conference in the US.
The conference falls in line with the company’s strategy of presenting the benefits of PromarkerD to the movers and shakers of the medical industry at global health forums.
Results from the retrospective study also add to other positive outcomes from evaluation of PromarkerD in the US.
More than three-quarters of surveyed physicians in a recent clinical utility study said they were very likely or extremely likely to use PromarkerD in the future. The US study showed that PromarkerD tests were more important to physicians than current standard of care tests.
An economic health benefit study conducted earlier in the year by independent consultant, Boston Healthcare Associates modelled the budget impact of PromarkerD against existing care standards in the US. It concluded PromarkerD testing could result in a mammoth US$384 billion savings to the US healthcare system over a decade.
Early and cost-effective prediction of Diabetic Kidney Disease could reduce the need for expensive treatment at later stages of the disease, such as dialysis and kidney transplants and the weight of evidence appears to be growing for PromarkerD’s predictive ability.
Management says dialysis alone can cost patients US$72,000 each year, with total cost of diabetic kidney disease in the US estimated at US$130 billion each year.
The pieces seem to be falling into place for Proteomics and the latest retrospective evaluation of PromarkerD appears to have taken the Perth-based company a step closer to tapping into the lucrative US medical market.
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