Proteomics International (ASX:PIQ) has secured a significant milestone in its push into the US healthcare market, with Medicare authorities setting a national reimbursement price of US$390.75 for its PromarkerD test, a predictive diagnostic for diabetic kidney disease.
The decision, published by the US Centers for Medicare and Medicaid Services (CMS), provides the first clear national payment pathway for the test and is expected to accelerate adoption across the world’s largest healthcare market when the price takes effect on 1 January 2026.
The new reimbursement follows the earlier approval by the American Medical Association of a unique CPT Proprietary Laboratory Analyses (PLA) code (0579U), giving PromarkerD a dedicated billing identity within the US health system. Together, CMS pricing and the PLA code create the conditions for broad clinical access as Proteomics International prepares for its full-scale US rollout.
Managing Director Dr Richard Lipscombe said the decision represents a defining moment for the company. “The new CMS pricing determination and PLA code for PromarkerD are pivotal to our next phase of commercialisation in the United States,” he said. “The CMS decision validates the clinical and economic value of PromarkerD and ensures a clear reimbursement pathway for healthcare providers. This will drive adoption, patient access, and commercial partnerships in the United States.”
With more than 32 million adults in the US living with diabetes, early identification of diabetic kidney disease (DKD) remains one of the greatest unmet needs in chronic disease management. DKD costs the US healthcare system over US$130 billion annually, driven mainly by dialysis and transplant.
PromarkerD is the only predictive blood test that can identify otherwise healthy type 2 diabetes patients at risk of developing DKD up to 4 years before clinical symptoms appear. Published studies show the test can correctly predict disease onset in up to 86 per cent of patients.
By identifying patients early, physicians can intervene with SGLT2 inhibitors, GLP-1 agonists and other kidney-protective therapies before irreversible damage occurs.
CMS is the largest single payer in the US, accounting for roughly 42 per cent of total healthcare expenditure through Medicare and Medicaid. Its reimbursement decisions often shape private insurers' behaviour, who routinely reference CMS benchmarks when establishing their own coverage policies.
PromarkerD is already available in California through the company’s CLIA-certified reference laboratory, providing a platform for scaling testing volume under the US regulatory system.