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Clinical Validation Study confirms PromarkerD can predict Diabetic Kidney Disease better than any Current Measure



- PromarkerD predicted 86% of disease-free patients who went on to develop chronic kidney disease within four years
- Largest prospective clinical study on diabetic kidney disease in the community, evaluating 792 patients over 4yr period
- Presented at American Diabetes Association's 77th Annual Scientific Sessions, 9-13th June in San Diego


Managing Director Dr Richard Lipscombe in PILL Laboratories, Harry Perkins Institute of Medical Research, Perth, Western Australia

SAN DIEGO, CA, June 12, 2017 - (ACN Newswire) - Proteomics International Laboratories Ltd ('PILL', ASX: PIQ), a global leader in applying proteomics to MedTech, has announced results from the clinical validation study showing that its PromarkerD blood test can predict the onset of diabetic kidney disease (DKD) better than any current measure.

The findings were presented by Professor Tim Davis, from The University of Western Australia Medical School, at the American Diabetes Association's 77th Annual Scientific Sessions (ADA), 9-13th June, in San Diego, California. (ADA Abstract #2017-LB-7091-Diabetes)

The study, undertaken as a joint collaboration between Proteomics International and The University of Western Australia, is the largest prospective clinical study on diabetic kidney disease in the community and evaluated the clinical utility of PromarkerD with 792 patients.

In March, Frost & Sullivan identified PromarkerD as the world's leading test for diabetic kidney disease, and the new results confirm PromarkerD predicts rapid decline in kidney function in type 2 diabetes, across clinically significant definitions of disease, independently of recognised clinical risk factors.

According to the International Diabetes Federation, 415 million adults had diabetes in 2015. The US Center for Disease Control states that one in three adult diabetics have chronic kidney disease, or 138 million people today. Once detected, chronic kidney disease can be treated through medication and lifestyle changes to slow down the disease progression, and to prevent or delay the onset of kidney failure.

The International Diabetes Federation further predicts the number of diabetics will rise to 642 million by 2040, which, if unchecked, will increase the number of adults with chronic kidney disease by 76 million to 214 million. The current cost of dialysis is estimated at $100,000 per person per year.

The validation study (assessing the performance of the prediction model in an independent population) confirms results from the original development study, also completed in collaboration with Professor Davis. Initial findings on the diagnostic performance of PromarkerD were published in the European Journal of Proteomics in March 2017.

In the four-year prospective study, the three protein marker (biomarker) blood test (PromarkerD) predicted 86% of previously disease-free patients who went on to develop chronic kidney disease (Sensitivity 86%, Specificity 78%, AUC 0.88). In comparison to the development study, the results from the larger validation study showed slightly lower levels of predictive ability (development 95%), however, it achieved a 10% improvement in levels of false positives.

Professor Davis concluded, "The data support the use of the protein biomarker panel in conjunction with eGFR (estimated glomerular filtration rate) in patients with type 2 diabetes to monitor and predict their decline in kidney function."

"This large clinical study validates the important role of the PromarkerD test to effectively monitor patients with diabetes," said Dr Richard Lipscombe, Managing Director of Proteomics International. "Although patients may appear to be adequately controlled for the complications of diabetes, current tests do not reveal early symptoms of kidney disease, which can result in the need for dialysis or kidney transplant."

The annual ADA Scientific Sessions are the world's largest and most prominent meeting of diabetes experts, attracting more than 13,000 delegates. The results were reported in the Late-breaking Abstracts section of the conference, titled "Novel Circulating Biomarkers Predicting Rapidly Declining Renal Function in Type 2 Diabetes: The Fremantle Diabetes Study". PILL's head of business development Chuck Morrison is also attending the event.

PromarkerD - a predictive diagnostic test for diabetic kidney disease (www.PromarkerD.com)

PromarkerD is a breakthrough blood test that uses a protein 'fingerprint' to measure kidney disease in patients with diabetes. This ground-breaking test can both diagnose and predict disease. A published study in a peer-reviewed journal has shown that for diabetic patients already suffering from chronic kidney disease PromarkerD can diagnose the presence of disease that was missed by the current gold standard tests (known as the ACR and eGFR tests).

Critically, PromarkerD can also predict the onset of disease before clinical symptoms appear. In the current study 792 patients were followed in dual, four-year longitudinal clinical studies. PromarkerD correctly predicted 86% of the previously kidney disease-free diabetic patients who went on to develop chronic kidney disease.

The Frost & Sullivan report titled "Biomarkers Enabling Diabetes and Obesity Management" is available via PILL's website (www.proteomicsinternational.com).

For further information, please contact:

Chuck Morrison
Head of Business Development
Proteomics International
T: +1 617 331 2975
E: [email protected]

Dr Richard Lipscombe
Managing Director
Proteomics International Laboratories Ltd
T: +61 8 9389 1992
E: [email protected]

Susan Fitzpatrick-Napier [Media Contact]
Digital Mantra Group
T: +1 650 798 5238
T: +61 2 8218 2144
E: [email protected]

Arun Sengupta [Investor Relations]
Director, Canary Capital
T: +61 417 617 181
E: [email protected]

The Fremantle Diabetes Study (FDS)

The Fremantle Diabetes Study is a longitudinal observational study of a community-based, urban population in Fremantle, Western Australia. The study, which commenced in 1993 with a more recent phase II in 2008, contains over 3,000 recruits, and is headed by Professor Tim Davis of Fremantle Hospital and the Medical School at The University of Western Australia. The strengths of the FDS are the inclusive and representative nature of the cohorts, the range and detail of data collection and linkage to well-established morbidity and mortality databases. The design and implementation of the FDS means that specific questions regarding the natural history of diabetes, its impact on the individual and its costs can be addressed with relative rigour.

The University of Western Australia

Ranked in the world's top 100 universities, The University of Western Australia (UWA) is Western Australia's first university and has an international reputation for excellence in education, research and community engagement. The University is located alongside the Swan River, five kilometres from the heart of Perth city. UWA's cutting-edge research attracts high levels of competitive research funding and researchers who are global leaders in their field.

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

Proteomics International is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company focused on proteomics -- the industrial scale study of the structure and function of proteins. PILL is recognised as a global leader in the field of proteomics. It received the world?s first ISO 17025 laboratory accreditation for proteomics services, and operates from state-of-the-art facilities located on the QEII Medical Campus in Perth, Western Australia. The Company's business model uses its proprietary technology platform across three integrated areas of diagnostics, drug discovery and analytical services.


Source: Proteomics International Laboratories Ltd (PILL)

Copyright 2017 ACN Newswire . All rights reserved.

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