PromarkerD Launch Targets 32 Million US Diabetes Patients at Risk of Kidney Disease

A New Frontier in Diabetes Care

Proteomics International Laboratories Ltd (ASX, PIQ) has taken a significant step in its global commercialisation strategy by launching PromarkerD in the United States. This blood test, designed to predict diabetic kidney disease (DKD) up to four years before symptoms appear, was unveiled at the 85th Scientific Sessions of the American Diabetes Association in Chicago; the largest annual gathering of diabetes professionals worldwide.

PromarkerD’s ability to identify early kidney function decline in type 2 diabetes patients addresses a critical unmet need. With half of all adults with diabetes developing kidney disease, early detection is essential to prevent irreversible damage and costly treatments such as dialysis or transplantation.

Strategic US Market Entry

The test is initially available in California through Proteomics International’s newly established Clinical Laboratory Improvement Amendment (CLIA) certified reference laboratory in Irvine. This launch serves as a pilot for broader US rollout, leveraging a hybrid commercialisation model that combines direct-to-consumer engagement with partnerships and insurance industry discussions.

Proteomics International’s Managing Director, Dr Richard Lipscombe, highlighted the launch as a milestone that underscores the company’s commitment to precision medicine in tackling the diabetes epidemic. The company plans to engage healthcare providers, patient advocacy groups, and opinion leaders to demonstrate PromarkerD’s clinical utility through real-world case studies and late-breaking research presentations.

Addressing a Massive Healthcare Burden

The US healthcare system faces an enormous financial strain from diabetic kidney disease, with costs exceeding $130 billion annually; more than a quarter of Medicare’s total budget. The American Society of Nephrology warns that early-stage kidney disease often goes undetected due to its asymptomatic nature, leading to irreversible damage by the time it is diagnosed.

By enabling early intervention, PromarkerD has the potential to improve outcomes for over 32 million Americans living with diabetes, slowing disease progression and reducing the need for expensive treatments. Nurse practitioner Davida Kruger from Henry Ford Health in Detroit praised the test as a paradigm shift, allowing clinicians to implement preventative strategies well before kidney damage becomes irreversible.

Building on Australian Foundations

Proteomics International first launched PromarkerD in Australia earlier this year, focusing on Western Australia and the Northern Territory. This pilot program has helped refine the company’s direct-to-consumer platform and logistics ahead of the US expansion. The Australian laboratory operates under stringent quality standards, with accreditation pending from the National Association of Testing Authorities.

Looking ahead, the company aims to secure regulatory approvals and expand PromarkerD’s availability across the US, while advancing partnerships with insurers and healthcare providers to facilitate widespread adoption.