Proteomics International Laboratories has launched its groundbreaking PromarkerD test in the United States, marking a significant milestone in early detection of diabetic kidney disease. The predictive blood test was unveiled at the 85th Scientific Sessions of the American Diabetes Association in Chicago, the world's largest gathering of diabetes professionals.
Revolutionary Early Detection Technology
PromarkerD represents a paradigm shift in diabetes care by predicting the onset of diabetes-related chronic kidney disease (DKD) up to four years before clinical symptoms appear in patients with type 2 diabetes. The test addresses a critical unmet medical need, given that one in two adults with diabetes currently develop kidney disease.
The next-generation PromarkerD utilizes a high-throughput immunoassay that measures two plasma protein biomarkers - ApoA4 and CD5L - alongside age and estimated glomerular filtration rate (eGFR) to generate a personalized DKD risk score. This simplified approach aligns with routine pathology workflows while maintaining exceptional accuracy.
Clinical Validation and Performance
In a comprehensive clinical study involving 948 participants, the next-generation PromarkerD demonstrated remarkable predictive performance. The test correctly identified 86% of at-risk individuals who would develop diabetic kidney disease, all of whom were missed by current standard-of-care tests including eGFR and urinary albumin:creatinine ratio (uACR).
The high-risk PromarkerD group showed 44-fold greater odds of kidney decline compared to the low-risk group, demonstrating the test's exceptional discriminatory power. These findings were presented as a Late Breaking Abstract titled "Next-Generation PromarkerD vs Standard of Care for Assessing Kidney Function Decline in Type 2 Diabetes."
Addressing a Major Healthcare Challenge
The introduction of PromarkerD to the US market comes at a critical time. Diabetic kidney disease currently costs the US healthcare system $130 billion annually, equivalent to over a quarter of Medicare's total annual budget. Without effective intervention, projections indicate over one million US kidney failure patients by 2030.
According to the American Society of Nephrology, many patients suffer silently initially because chronic kidney disease is largely asymptomatic at the beginning. This lack of early detection can be fatal, as kidney dysfunction lasting longer than three months is often irreparable.
Market Launch and Availability
The test will initially be available in California through Proteomics International's recently opened Clinical Laboratory Improvement Amendment (CLIA) certified Reference Laboratory in Irvine. The company plans a broader US rollout as part of its hybrid commercialization strategy utilizing both direct-to-consumer and partner sales channels.
Dr. Richard Lipscombe, Managing Director of Proteomics International, stated, "We're excited to introduce PromarkerD to the US at such a prestigious event. This marks a significant milestone in our global commercialisation strategy and underscores our commitment to addressing the diabetes epidemic through precision medicine."
Clinical Impact and Expert Endorsement
Davida Kruger, a renowned diabetes care nurse practitioner at Henry Ford Health in Detroit, emphasized the test's transformative potential: "PromarkerD represents a paradigm shift in diabetes care. Early identification of patients at risk for kidney disease allows clinicians to implement preventative strategies long before irreversible damage occurs. This is the kind of innovation that transforms patient lives."
The test's ability to enable early intervention could significantly improve outcomes for over 32 million adults in the US with diabetes who are at risk of developing DKD. By identifying high-risk patients years before symptoms appear, clinicians can implement targeted preventative care to slow or prevent kidney function decline.
Global Expansion Strategy
PromarkerD has already been launched in Australia on World Kidney Day through a clinician-driven strategy supported by an online patient awareness campaign. The pilot program in Western Australia and the Northern Territory has enabled the company to refine its direct-to-consumer platform and logistics processes.
The US launch represents a fundamental step in the company's commercialization strategy, with real-world use facilitating discussions with potential license and distribution partners and the health insurance industry. The test is now positioned for global commercialization and regulatory expansion, opening new pathways to transform diabetic care through precision medicine.
