Proteomics International Laboratories Ltd (PIQLF) Next-gen PromarkerD test system released for predicting DKD

Proteomics International Laboratories Ltd (ASX:PIQ) (OTCMKTS:PIQLF), a pioneer in precision diagnostics, is pleased to announce the successful development and release of the next-generation of the PromarkerD test system, a simplified, immunoassay-based diagnostic that accurately predicts kidney function decline in adults with type 2 diabetes (T2D).

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

- The next-generation PromarkerD utilises a high-throughput immunoassay to measure two plasma protein biomarkers alongside two clinical factors to generate a personalised DKD risk score

- Results presented over the weekend at the 85th Scientific Sessions of the American Diabetes Association in Chicago, Illinois, the largest gathering of diabetes professionals in the world

- Simplified without compromising accuracy, the next-gen PromarkerD matched previously published performance identifying 86% of at-risk individuals, all missed by standard tests

In results presented over the weekend at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois, this technology builds upon PromarkerD's proven clinical utility and represents a key advancement toward large-scale clinical deployment in pathology laboratories globally.

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.

The next-generation PromarkerD utilises a high-throughput 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.

Simplified without compromising accuracy, the next-gen PromarkerD matched previously published performance [ASX 11 March], and identified 86% of at-risk individuals, all missed by current standard-ofcare eGFR and urinary albumin:creatinine ratio (uACR) tests.

In a 948 participant clinical study, the test retained its excellent predictive discrimination, with the high-risk PromarkerD group demonstrating 44-fold greater odds of kidney decline vs the low-risk group. The key clinical validation data was presented as a Late Breaking Abstract, a program for the inclusion of noteworthy and timely research advances, titled "Next-Generation PromarkerD vs Standard of Care for Assessing Kidney Function Decline in Type 2 Diabetes" [Copy of presentation attached below*].

PromarkerD is now positioned for global commercialisation and regulatory expansion, opening new pathways to transform diabetic care through precision medicine.

About PromarkerD (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. Further information on DKD is available through the www.mytest.health web portal.

*To view the Presentation, please visit:
https://abnnewswire.net/lnk/8Z5FI5ST

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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