American Medical Association grants Proteomics International's NextGeneration PromarkerD test a dedicated CPT PLA Reimbursement Code
AMA grants reimbursement code for Next-Gen PromarkerD test
Perth, July 3, 2025 AEST (ABN Newswire) - Proteomics International Laboratories Ltd (
ASX:PIQ) (PIQLF:OTCMKTS), a pioneer in precision diagnostics, is pleased to announce the assignment of billing code (0579U) by the American Medical Association (AMA) for the next-generation of the PromarkerD test system. This next-generation PromarkerD test is a simplified, immunoassay-based diagnostic that accurately predicts kidney function decline in adults with type 2 diabetes (T2D).
In addition, on June 27, 2025, Proteomics International presented to the Centers for Medicare and Medicaid Services (CMS) its pricing recommendation for the test beginning in 2026. CMS will release its preliminary pricing for the test in September after consulting with its Advisory Panel for Clinical Diagnostic Laboratory Tests.
Diabetes-related chronic kidney disease (DKD), is a major global health burden. The PromarkerD test addresses a critical unmet need by the identification of individuals at risk of DKD up to four years before clinical symptoms appear. This early identification enables targeted, preventative care to reduce progression to costly and life-threatening end-stage renal disease requiring dialysis or kidney transplant.
Proteomics International Managing Director Dr Richard Lipscombe said, "Ensuring kidney health is a priority for our company and obtaining this dedicated PLA code is a crucial milestone in our strategy to improve access to meaningful diagnostic tests. Expanding access to PromarkerD will help to improve kidney health for patients everywhere."
CPT(R), or Current Procedural Terminology, codes are widely used across the US to report medical procedures and services under public and private health insurance programs. A CPT PLA code uniquely identifies a test for the testing laboratory, enabling healthcare providers to order the test, facilitates a billing pathway for payers, and permits monitoring of test usage.
The newly-approved code for PromarkerD has been published and will be effective for claims submitted on or after 1 October 2025. The PLA code was issued to Proteomics International USA Inc for the Company's CLIA certified reference laboratory [ASX 28 February].
PromarkerD is now positioned for global commercialisation and regulatory expansion, opening new pathways to transform diabetic care through precision medicine. The next-generation PromarkerD test was launched into the US last month at the annual meeting of the American Diabetes Association [ASX 20 June, 23 June].
About Promarker(R)D (www.PromarkerD.com)
Diabetes-related chronic kidney disease (DKD) is a serious complication arising from diabetes which if unchecked can lead to dialysis or kidney transplant. PromarkerD is a prognostic test that can predict future kidney function decline in patients with type 2 diabetes and no existing DKD. The patented PromarkerD test system uses a blood test to detect a unique 'fingerprint' of the early onset of the disease. The multivariate test measures a select panel of protein and clinical biomarkers, before a cloud-based algorithm integrates the results into a patient risk report. In clinical studies published in leading journals PromarkerD correctly predicted up to 86% of otherwise healthy diabetics who went on to develop diabetic kidney disease within four years. Country specific use of this product is subject to the relevant regulatory approvals.
Proteomics International recommends that patients concerned about DKD seek advice from their doctors.
About Proteomics International Laboratories Ltd
Proteomics International Laboratories (ASX:PIQ) is a wholly owned subsidiary and trading name of PILL, a medical technology company at the forefront of predictive diagnostics and bioanalytical services. The Company specialises in the area of proteomics - the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.
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