Proteomics International Secures $390 Medicare Reimbursement for Kidney Disease Test
Proteomics International secures a key Medicare reimbursement rate for its PromarkerD test, a predictive diagnostic for diabetic kidney disease, marking a critical step in its US commercial rollout.
- US Medicare reimbursement set at $390.75 for next-gen PromarkerD test
- CMS pricing supports broader patient access and private payer negotiations
- PromarkerD predicts diabetic kidney disease risk up to four years early
- Potential to impact care for 32 million US adults with diabetes
- DKD-related healthcare costs in the US exceed $130 billion annually
Medicare Pricing Milestone
Proteomics International Laboratories Ltd (ASX – PIQ) has achieved a significant commercial breakthrough with the US Centers for Medicare & Medicaid Services (CMS) setting a reimbursement price of US$390.75 for its next-generation PromarkerD test. Effective from January 1, 2026, this pricing under the Clinical Laboratory Fee Schedule is a pivotal step in the company’s US market strategy, enabling broader clinical access through Medicare, the largest single healthcare payer in the United States.
Strengthening Market Position
The CMS determination not only validates the clinical and economic value of PromarkerD but also bolsters Proteomics International’s negotiations with private insurers and strategic partners. Private payers often benchmark their reimbursement rates against CMS pricing, amplifying the commercial reach of this decision. This development follows the earlier assignment of a unique CPT Proprietary Laboratory Analyses (PLA) code, which provides a dedicated billing pathway for the test.
Innovative Predictive Diagnostic
PromarkerD is a blood-based test that predicts the risk of diabetic kidney disease (DKD) in patients with type 2 diabetes up to four years before symptoms appear. Early identification allows physicians to initiate renal-protective therapies, potentially slowing or preventing kidney function decline. Clinical studies have shown PromarkerD can correctly predict up to 86% of patients who will develop DKD, offering a powerful tool for preventive care.
Addressing a Large Unmet Need
With over 32 million adults in the US living with diabetes, the burden of DKD is substantial, with healthcare costs exceeding $130 billion annually. By enabling earlier intervention, PromarkerD could reduce the incidence of costly treatments such as dialysis and kidney transplants, improving patient outcomes and delivering significant cost savings to the healthcare system.
Next Steps in Commercialisation
Proteomics International is now focused on securing private health insurer coverage alongside Medicare through programs such as the Molecular Diagnostic Services Program (MolDX) and Local Coverage Determinations (LCDs). The company’s existing CLIA-certified laboratory in California ensures regulatory compliance and scalability as it prepares for a broader US rollout in 2026.
Bottom Line?
CMS reimbursement pricing unlocks US market potential, but private payer uptake will be the true test.
Questions in the middle?
- How quickly will private insurers adopt PromarkerD coverage following CMS pricing?
- What impact will PromarkerD have on clinical practice and patient outcomes in real-world settings?
- How will competitors in the diabetic kidney disease diagnostic space respond to this milestone?
