Proteomics International managing director Dr Richard Lipscombe said: “The new CMS pricing determination and PLA code for PromarkerD are pivotal to our next phase of commercialisation in the United States. This will drive adoption, patient access, and commercial partnerships in the United States.”
The timing of the CMS decision could hardly be better. More than 32 million adults in the United States live with diabetes and diabetic kidney disease is one of the nation’s most devastating and expensive complications. Kidney failure, dialysis and transplants together fuel a staggering US$130 billion (A$200 billion) annual healthcare bill – more than a quarter of Medicare’s entire budget.
Although Proteomics already has supplies of the PromarkerD test available for sale through its CLIA-certified reference lab in California, the latest decision throws open the doors for some serious scaling.
Armed with its own American Medical Association PLA code and a set Medicare reimbursement price, the company says it now has the regulatory plumbing laid down for national billing.
The next step is to chase up private insurer coverage, moving through Palmetto GBA’s influential Molecular Diagnostic Services Program (MolDX) program and landing local coverage approvals to cement access across all 50 states in the US.
While today’s news firmly plants a sizeable Proteomics flag in the United States, the broader opportunity is enormous, with 537 million adults worldwide living with diabetes.
For a Perth-based company built on the deep science of proteomics, US Medicare’s backing is a significant victory and one that could change how diabetic kidney disease is detected and managed across the globe.
With reimbursement secured and a US rollout now within reach, Proteomics appears poised to turn years of research into real-world impact. If PromarkerD can move the needle in America, the global market may not be far behind.
And the market would tend to agree. The company’s share price has raced higher today, up as much as 29 per cent to 44.5 cent a share on the best turnover in more than a month.
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