Proteomics International Laboratories Ltd (PIQLF) Next-Gen PromarkerD Test Performance Results Published

Proteomics International Laboratories Ltd (ASX:PIQ) (OTCMKTS:PIQLF), a pioneer in precision diagnostics, is pleased to announce the publication of results demonstrating the accuracy and performance of its next-generation PromarkerD test system, a simplified, immunoassay-based diagnostic that accurately predicts kidney function decline in adults with type 2 diabetes (T2D). The key results reported in the publication were first presented at the 85th Scientific Sessions of the American Diabetes Association (ADA) [ASX 23 June].

Performance of Next-Generation PromarkerD Test System published in The Journal of Applied Laboratory Medicine

- PromarkerD is a blood test validated for predicting diabetes-related chronic kidney disease (DKD) up to four years before symptoms appear

- Simplified without compromising accuracy, the next-generation PromarkerD test system utilises a high-throughput immunoassay to generate a personalised DKD risk score

- Results published overnight in the peer-reviewed Journal of Applied Laboratory Medicine

- In a study of over 1,700 participants the next-generation PromarkerD test demonstrated:

o excellent predictive discrimination, with patients predicted as high-risk by PromarkerD having 44-fold greater odds of kidney decline versus the low-risk group

o exceptional predictive performance (AUC 0.88) and negative predictive value up to 97.4%, outperforming current standard of care tests

o excellent analytical precision, reproducibility, and stability, meeting stringent international laboratory guidelines

o matched previously published performance identifying 86% of individuals at risk of DKD, all missed by standard tests

- Major health impact: Potential to improve outcomes for 537 million adults globally with diabetes and at risk of DKD by enabling earlier intervention, improving care and reducing healthcare costs

- Next-Gen PromarkerD test is now available to Type-2 diabetes patients in both Australia & USA

Diabetes-related chronic kidney disease (DKD) is a major global health burden. The next-generation PromarkerD test addresses a critical unmet need in diabetes management by identifying patients at risk of DKD up to four years before clinical symptoms appear. This early identification by PromarkerD enables targeted, preventative care to reduce progression to costly and life-threatening end-stage renal disease requiring dialysis or kidney transplant.

Published overnight in the peer-reviewed Journal of Applied Laboratory Medicine, the study highlighted the test's strong predictive performance across diverse groups, and its high negative predictive value accurately rules out future kidney decline, enabling targeted care and better resource allocation.

Simplified without compromising accuracy, the next-generation PromarkerD test system utilises a highthroughput immunoassay that aligns with routine pathology workflows. The test now measures two plasma protein biomarkers (ApoA4 and CD5L) alongside age and estimated glomerular filtration rate (eGFR) to generate a personalised DKD risk score.

In the 949-participant community based Fremantle Diabetes Study Phase II (FDS2), the test achieved exceptional predictive performance (AUC 0.88) and negative predictive value (NPV) of 97.4%, outperforming current standard of care tests eGFR and urinary albumin:creatinine ratio (uACR). External validation in the 757-participant CANagliflozin CardioVascular Assessment Study (CANVAS) cohort further confirmed robustness (AUC 0.78, NPV 95.1%).

Notably, patients predicted as high-risk by PromarkerD had a 44-fold greater odds of kidney decline versus the low-risk group. The next-generation version of the test matched previously published performance [ASX 11 March] by identifying 86% of individuals at-risk of DKD, all missed by current standard-of-care.

The next-gen PromarkerD test also demonstrates excellent analytical precision, reproducibility, and stability, meeting stringent international guidelines (Clinical & Laboratory Standards Institute (CLSI) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)).

This technology refinement builds upon PromarkerD's proven clinical utility and represents a key advancement towards large-scale clinical deployment in pathology laboratories globally, opening new pathways to transform diabetic care through precision medicine.

Dr Richard Lipscombe
Managing Director
Proteomics International Laboratories Ltd
T: +61 8 9389 1992
E: enquiries@proteomicsinternational.com

Dirk van Dissel 
Investor Relations and Corporate Advisor
Candour Advisory
T: +61 408 326 367 
E: dirk@candouradvisory.com.au

Matthew Wright
Media and Public Relations
NWR Communications
T: +61 451 896 420
E: matt@nwrcommunications.com.au

Proteomics International (Europe)
Plesmanweg 9, 7602 PD Almelo
The Netherlands
T: +31 85 40 11 173
E: Europe@PromarkerD.eu

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