US Medicare sets cracking unit price for Proteomics diabetes test

The Centers for Medicare & Medicaid Services, otherwise known as Medicare, which is headquartered in Baltimore in the United States.

Proteomics International (ASX: PIQ) has notched up a major win in the US, with the nation’s powerful Medicare system setting a reimbursement price of US$390.75 (A$604) for the company’s groundbreaking PromarkerD predictive kidney disease blood test.

The Centers for Medicare & Medicaid Services (CMS) ruling effectively hands the medical technology developer the keys to America’s vast healthcare market and strengthens its pitch to private insurers just as the company gears up for a major national rollout in 2026.

Dispensed as a simple blood test, PromarkerD uses a panel of protein and clinical biomarkers to detect a biochemical “fingerprint” in patients who are likely to develop diabetic kidney disease up to four years before any symptoms appear.

Spotting the earliest signs of diabetic kidney disease gives doctors a crucial window to deploy proven renal-protective therapies - such as SGLT2 inhibitors and GLP-1 agonists - long before patients slide into dangerous and expensive end-stage kidney failure, where dialysis or a transplant becomes the only option.

Recent clinical studies found the test correctly predicted kidney function decline in 86 per cent in type-2 diabetics, echoing the success of earlier trials.

The CMS carries enormous influence in the US, with Medicare and Medicaid together making up around 42 per cent of healthcare spending, giving the agency unrivalled gatekeeper status.

Notably, CMS pricing often sets the benchmark for the broader market. Private health insurers, which cover tens of millions more Americans, regularly look to CMS rates when determining how they will reimburse tests and procedures.

Importantly for Proteomics, it also means the US$390.75 figure now becomes the starting point for discussions with insurers, clinical networks and strategic partners, all hungry for solutions that reduce costs and improve outcomes related to chronic kidney disease.

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.

Proteomics International Managing Director Dr Richard Lipscombe

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 27.5 per cents to 42.5 cents a share on the best turnover in more than a month.

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