Medical technology innovator Proteomics says a US clinical utility study on its PromarkerD predictive test for diabetic kidney disease has shown the test to be “more important” to a physician who is monitoring a patient’s condition than the existing standard of care. Results of the study form a key cog in the company’s application for a ‘US reimbursement code’ that could result in costs of the test being reimbursed by insurance companies in the lucrative US market.
According to Proteomics, PromarkerD is the world’s only test for predicting the onset of kidney disease in type-two diabetes patients before clinical symptoms appear. The company says the test can predict a decline in renal function up to four years in advance.
Results of the clinical utility study come on the back of a survey of 400 primary care physicians and endocrinologists in the US. More than three-quarters of the surveyed physicians reported they were very likely or extremely likely to use PromarkerD in the future, according to Proteomics.
Management says the new study has shown that PromarkerD can assist doctors in making better informed treatment decisions and can improve clinical outcomes for patients with type-two diabetes.
The study also concluded patients who recorded a PromarkerD test result showing a high-risk of developing diabetic kidney disease were more likely to have their monitoring frequency increased.
The findings demonstrate PromarkerD’s appeal to clinicians and payors in the management of diabetes. This study shows PromarkerD offers a cost-effective, personalised approach to improving patient outcomes. It allows earlier targeted treatment of those patients at highest risk of diabetic kidney disease, while avoiding unnecessary interventions for people at low risk.
Results from the new study add to a previous economic health benefit study that demonstrated the potential cost savings to the US healthcare system if PromarkerD was adopted.
The health benefit study, conducted by independent consultant Boston Healthcare Associates, modelled the budget impact of PromarkerD against existing care standards in the US. It concluded PromarkerD testing could lead to a whopping US$384 billion savings to the US healthcare system over a decade.
Importantly, results from the two studies form essential components for the company’s application for a ‘US reimbursement code’.
New reimbursement codes are approved by the American Medical Association on a quarterly basis after the economic health benefits and clinical outcomes of new tests are evaluated.
Successful acceptance of PromarkerD into the US reimbursement code system would allow for costs of the test to be reimbursed by insurance companies in the US, instead of coming out of a patient’s pockets.
Proteomics says the US alone accounts for about 31 million people at risk of developing diabetic kidney disease – an illness that results in some 40,000 deaths in the country each year.
Early and cost-effective prediction of kidney disease could reduce the need for expensive treatment at later stages of the disease, such as dialysis and kidney transplants.
Total cost of diabetic kidney disease in the US is estimated at US$130 billion annually, according to the company.
Proteomics is already in discussions with potential US laboratory partners for the uptake of its PromarkerD tests. The apparent positive outcomes from the clinical utility study appear to take the Australian company yet another step closer to taking its place in the lucrative US healthcare market.
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