US Medicare sets cracking unit price for Proteomics diabetes test
Dr Richard Lipscombe, managing director of Proteomics International, said: “Determining new CMS pricing and PLA code for PromarkerD is critical to our next phase of commercialization in the United States. “This will increase adoption, patient access, and commercial partnerships in the United States.”
The timing of the CMS decision could not have been 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 account for a staggering US$130 billion (AU$200 billion) annual healthcare bill; This accounts for more than a quarter of Medicare’s entire budget.
Although Proteomics has PromarkerD assay materials available for sale through its CLIA-certified reference laboratory in California, the latest decision opens the door to serious scaling.
Armed with its own American Medical Association PLA code and a set Medicare reimbursement price, the company says the regulatory plumbing for national billing is now established.
The next step is to pursue private insurance coverage by moving to Palmetto GBA’s effective Molecular Diagnostic Services Program (MolDX) program and obtaining local insurance coverage approvals to strengthen access in all 50 states in the US.
While today’s news firmly plants a major Proteomics flag in the United States, the broader opportunity is enormous, with 537 million adults living with diabetes worldwide.
For a Perth-based company built on the science of deep proteomics, US Medicare’s support is a significant victory and one that could change the way diabetic kidney disease is detected and treated worldwide.
With reimbursement secured and a U.S. launch now possible, Proteomics looks poised to translate 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 will tend to agree. The company’s share price rose as much as 29 percent to 44.5 percent per share today, marking its best turnover in more than a month.
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