PromarkerD significantly outperforms current standard of care tests in predicting future kidney function decline

Study shows PromarkerD is significantly better than current standard of care tests eGFR and ACR for predicting future decline in kidney function in patients with type 2 diabetes
PromarkerD correctly identified 84% of patients with normal kidney function that went on to experience kidney function decline that would be missed by standard of care tests
For patients whose kidney function did not decline PromarkerD demonstrated a higher "rule-out" rate and considerably less false positives than standard of care testing
PromarkerD predictive testing for diabetic kidney disease could reduce the risk of dialysis or kidney transplant leading to significant cost savings for healthcare systems
Results presented at the American Society of Nephrology Kidney Week 2021 meeting

PERTH, Australia, Nov. 5, 2021 /PRNewswire/ -- Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) is pleased to announce the results of a study demonstrating that the PromarkerD test for diabetic kidney disease outperforms current standard of care tests in predicting kidney function decline in type 2 diabetes.

The research, presented at Kidney Week 2021, the annual meeting of the American Society of Nephrology (ASN), compared the PromarkerD test to current standard of care tests, the estimated glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio (ACR). The study updates and extends previous analysis and constitutes a core body of evidence underpinning the performance of PromarkerD for submissions to global regulators.

The results showed PromarkerD outperformed the current tests in predicting the onset of diabetic kidney disease during the four-year follow-up period. The study involved retrospective analysis of more than 850 community-based patients with type 2 diabetes from the Fremantle Diabetes Study Phase II.

In the study, PromarkerD correctly identified 84% of patients with normal kidney function who went on to experience kidney function decline in the next four years. Critically, all of these patients would have been missed by the eGFR and ACR tests which constitute the current gold standard of care under the global KDIGO (Kidney Disease Improving Clinical Outcomes) guidelines for risk classification[1]. PromarkerD also identified 89% of patients with abnormal kidney function who declined further over the course of the study.

The PromarkerD test measures the level of three plasma biomarkers in the blood. These are combined with clinical data in a validated algorithm to provide a PromarkerD score categorised as low, moderate or high risk.

[1] Kidney Disease Improving Clinical Outcomes (KDIGO) Guideline Development Working Group, Kidney Int. Suppl. 2013;3:1-150

The study found patients classified by PromarkerD as high risk were 21 times more likely to develop diabetic kidney disease (DKD) within four years than those classified as low risk. Patients classified as moderate risk by PromarkerD were 8 times more likely than low-risk patients to develop the disease.

PromarkerD also had significantly higher (P <0.001) predictive performance (AUC = 0.88) compared to eGFR (0.82), ACR (0.63), and eGFR and ACR combined (0.82).

Across all KDIGO categories of diabetes and kidney disease PromarkerD exhibited an excellent "rule-out" rate (Negative Predictive Value [NPV] >96%), for categorising patients at low risk of developing DKD, and demonstrated considerably less false positives compared to standard of care testing.

Proteomics International managing director Dr Richard Lipscombe said PromarkerD testing can help improve the management of diabetes for both patients and the healthcare system. "PromarkerD gives doctors the data they need to support early introduction of preventive medications to slow the progression of DKD in high-risk patients, closer monitoring of risk factors in moderate-risk patients, and rationalised treatment options in low-risk patients," he said.

ASN Kidney Week[2] is the largest nephrology conference in the United States, attracting over 10,000 attendees. This year, the virtual event will be held from 4-7 November 2021. The results are being presented as a scientific e-poster titled:

A Comparison of PromarkerD to Standard of Care Tests for Predicting Renal Decline

in Type 2 Diabetes

The conference forms part of the Company's ongoing strategy to engage with Key Opinion Leaders (KOL's), physicians and industry representatives at global health forums to show the benefits of implementing PromarkerD testing. In October, Proteomics International's announced results of a clinical utility study demonstrating that PromarkerD tests were more important to physicians than the current standard of care tests with more than three-quarters of physicians reporting they were very or extremely likely to use PromarkerD in the future. In May and June, the Company presented an economic health benefit study demonstrating the potential cost savings to the US healthcare system if PromarkerD was adopted, compared to the current standard of care.

Glossary

Sensitivity (Sn) (true positive rate)	The ability of a test to correctly identify those with the disease.
Specificity (Sp) (true negative rate)	The ability of the test to correctly identify those without the disease.
Negative Predictive Value (NPV)	The probability that people who get a negative test result truly do not have the disease. In other words, it is the probability that a negative test result is accurate.
Positive Predictive Value (PPV)	The probability that a patient with a positive (abnormal) test result actually has the disease. When the occurrence of a disease is low, the positive predictive value will also be low, even using a test with high sensitivity and specificity.
AUC	"Area Under the ROC Curve". A receiver operating characteristic curve, or ROC curve, is a graphical plot that illustrates the performance of a classifier system.
Interpreting AUC values	Conventionally the clinical significance of AUC is: > 0.7 acceptable discrimination > 0.8 excellent discrimination > 0.9 outstanding discrimination
PromarkerD algorithm	The power of the PromarkerD test system is that it can be calibrated to provide optimal results: - Maximise sensitivity or PPV to capture those at high risk of progressing towards dialysis or kidney transplant - Maximise specificity or NPV to rule-out those who are at low risk of progressing towards dialysis or kidney transplant

About PromarkerD (www.PromarkerD.com) Diabetic 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 simple blood test to detect a unique 'fingerprint' of the early onset of the disease by measuring three serum protein biomarkers, combined with three routinely available conventional clinical variables (age, HDL-cholesterol and estimated glomerular filtration rate (eGFR)). 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. The PromarkerD test is CE Mark registered in the European Union.

Further information is available through the PromarkerD web portal.

To visit the PromarkerD virtual booth please see: www.PromarkerD.com/product

About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com)

Proteomics International (Perth, Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company at the forefront of predictive diagnostics and bio-analytical 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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