Proteomics International Laboratories is nudging closer to commercialising its PromarkerD predictive test for diabetic kidney disease (DKD) after nailing down a payment rate of US$390.75 (AU$596) with the United States’ Centres for Medicare and Medicaid Services (CMS).
The company says the CMS reimbursement price will enable affordable access to PromarkerD for millions of Americans living with Type 2 diabetes and help drive broad adoption of the test. Additionally, management notes many private insurers follow CMS pricing.
The US health system is an eclectic mix of public and private healthcare providers. The national Medicare program provides funding for adults aged 65 and older, while Medicaid covers children, veterans and eligible low-income Americans.
Providing health coverage to more than 100 million Americans, CMS is the biggest government-funded healthcare provider in the US, accounting for 42 per cent of that nation’s healthcare spending.
The reimbursement price comes after the American Medical Association approved a unique proprietary laboratory analyses code for Proteomics’ PromakerD earlier this year. It is a prognostic test that can predict future kidney function decline in patients living with Type 2 diabetes, but who have no existing DKD.
The patented test uses a simple blood test to detect a unique “fingerprint” of the early onset of the disease by measuring three protein markers, combined with three routinely available, conventional clinical variables that include age, high-density lipoprotein cholesterol and estimated glomerular filtration rate.
A cloud-based algorithm, the “PromarkerD Hub” integrates the results into a patient risk report, classifying patients as low, moderate or high-risk.
Proteomics says clinical studies published in leading journals show PromarkerD correctly predicted up to 86 per cent of otherwise healthy diabetics, who went on to develop DKD, up to four years before clinical symptoms appeared.
Early diagnosis of DKD using PromakerD would allow doctors to adopt renal-protective interventions in patients at high risk for kidney decline, markedly improving clinical outcomes.
Importantly, delaying the progression of the disease would likely reduce the incidence of aggressive treatments, including dialysis and kidney transplant, improving quality of life for patients and saving healthcare systems millions of dollars.
Globally, there are 537 million adults living with diabetes – a daunting tally which is forecast to reach 783 million by 2045. In the US alone, an estimated 32 million people – or 11 per cent of the adult population – live with diabetes, costing that country a whopping US$130 (AU$198) billion per year.
With an exclusive licence deal stitched up with strategic business partner, Sonic Healthcare USA, together with CMS confirming its reimbursement rate, Proteomics is on track to roll out its innovative predictive diabetic kidney test in the first quarter of next year.
That would signify a major milestone and offer the opportunity to turbocharge its revenue streams. Should the sales bell ring loudly in the US, it could mark a pivotal year for Proteomics.
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