PromarkerD Secures CPT PLA Code, Paving Way for US Market Access

A Milestone in Diagnostic Reimbursement

Proteomics International Laboratories Ltd (ASX – PIQ) has achieved a significant commercial milestone with the American Medical Association's assignment of a dedicated CPT PLA reimbursement code (0579U) for its next-generation PromarkerD test. This immunoassay-based diagnostic tool predicts kidney function decline in adults with type 2 diabetes, addressing a critical unmet need in early detection of diabetic kidney disease (DKD).

The new billing code, effective from October 1, 2025, streamlines the ordering and reimbursement process for healthcare providers and payers across the United States. It marks a crucial step in integrating PromarkerD into routine clinical practice, facilitating easier access for patients at risk of DKD.

Implications for Patients and Healthcare Systems

Diabetes-related chronic kidney disease is a major global health challenge, often progressing silently until advanced stages requiring dialysis or transplantation. PromarkerD’s ability to predict kidney decline up to four years before symptoms emerge enables earlier intervention and personalized care strategies, potentially reducing the burden on healthcare systems and improving patient outcomes.

Proteomics International’s Managing Director, Dr Richard Lipscombe, emphasised the importance of this milestone in expanding access to meaningful diagnostics that can transform diabetic care through precision medicine.

Next Steps – Pricing and Market Expansion

Following the CPT PLA code assignment, Proteomics International has submitted its pricing recommendation to the Centers for Medicare and Medicaid Services (CMS). CMS is expected to announce preliminary pricing in September 2025 after consulting with its advisory panel. The final reimbursement rates will be pivotal in determining the test’s commercial uptake in the US market.

With the US launch of the next-generation PromarkerD test at the American Diabetes Association meeting in June 2025, the company is well-positioned for global commercialisation and regulatory expansion, aiming to establish PromarkerD as a standard tool in diabetic kidney disease management worldwide.

Looking Ahead

While the CPT PLA code unlocks a critical pathway for billing and monitoring, the ultimate impact on Proteomics International’s growth will depend on CMS pricing decisions and market adoption rates. The company’s progress signals a promising future for precision diagnostics in chronic disease management, but investors will be watching closely for uptake trends and international regulatory developments.