The Promarker™ Pipeline
Proteomics International’s Promarker™ Platform for protein biomarker discovery is a multi-step process. Arrows indicate project progress as reported in The Company’s 2023 Annual Report.
Biomarker discovery, verification and analytical validation is available as a fee for service model, or through a collaborative partnership with Proteomics International. Read more.
The Promarker™ Platform is currently being used to investigate the protein ‘fingerprints’ associated with the following diseases of unmet need:
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Diabetic Kidney Disease
Status update: Commercialised
Three biomarkers for Diabetic Kidney Disease identified by the Promarker™ Platform have been verified, validated, and developed into a commercially available test: PromarkerD.
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Endometriosis
Status update: Clinical Validation study completed; Statistical analysis ongoing.
Endometriosis is a common and painful disease that affects one in nine women and girls [see Annual Report 2021: Window on the Science]. It occurs when tissue similar to the lining of the uterus grows into other parts of the body where it does not belong. At the moment, there is no simple way to test for the condition, which often causes pain and infertility, and costs Australia $9.7 billion each year.
The current gold standard for detection is an invasive laparoscopy, a surgical procedure where a camera is inserted into the pelvis through a small cut in the abdominal wall. On average, it takes women 7.5 years to be diagnosed. In August 2021, the Company signed a research agreement with the University of Melbourne and the Royal Women’s Hospital to collaborate on a non-invasive test for endometriosis. Proteomics International conducted a clinical validation study of its biomarkers on samples from the University of Melbourne and the Royal Women’s Hospital. Subsequent to the year end, the Company announced that an early version of its potential world-first blood test for endometriosis had successfully detected up to 78 per cent of people with the painful condition. The results were presented at the Fertility Society of Australia and New Zealand Annual Conference (FSANZ 2022). The Company will now seek to confirm the clinical performance of the new test in an independent patient cohort. To support this independent validation, Proteomics International announced an additional collaboration with St John of God Health Care.
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Giardia (causing gastroenteritis)
Status update: Project ceased.
Validation study results were inconclusive and the decision was made to terminate the current project plan.
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Asthma and Chronic Obstructive Pulmonary Disease (COPD)
Status update: Proof-of-concept study completed; clinical validation pending.
Proteomics International completed a proof-of-concept study that identified multiple novel protein biomarkers for obstructive airway disease. These biomarkers, once validated, have the potential to deliver a new diagnostic test for asthma and chronic obstructive pulmonary disease (COPD).
The proof-of-concept study, performed in collaboration with the Busselton Population Medical Research Institute, analysed plasma samples from 75 individuals with a range of symptoms including airway obstruction, atopy, bronchial hyper-responsiveness and healthy controls. The results were presented at the 27th Lorne Proteomics Symposium, Victoria.
Proteomics International will now work with its collaborators to validate the biomarkers in larger clinical cohorts and refine the panel of biomarkers into a potential new blood test for diagnosing obstructive airway disease. The Company also filed a patent application covering screening, diagnostic and prognostic methods of using these airway disease biomarkers.
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Plant Dieback (Phytophthora cinnamomi)
Status update: Discovery phase successfully completed. Validation phase to begin.
Proteomics International has an ongoing collaboration with the Centre for Crop and Disease Management (Curtin University) to target the plant pathogen Phytophthora cinnamomi, which is responsible for plant dieback that affects a wide variety of native plant species and premium crops such as avocados and macadamias. The estimated cost to the Australian economy is $160 million per year for damage to natural vegetation alone. Current investigations are focused on proteogenomic and proteomic analysis (determining the protein maps) of the life stages of the organism and how it infects its host. This may lead to a field test for the easier detection of infected soil, and has the potential to identify weaknesses in the pathogen that could be targeted to help eradicate this disease.
A large number of biomarkers for the identification of plant dieback have been discovered with the next step to determine their detection level in ‘real life’ samples of soil or plant material. This path is being pursued to develop a diagnostic test for the presence of Dieback.
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Diabetic Retinopathy
Status update: Discovery study complete. Proof-of-concept underway.
Following the success of the diabetic kidney disease project, Proteomics International extended its collaboration agreement with The University of Western Australia to seek early markers for diabetic retinopathy, the major cause of blindness in the US.
This collaboration is applying the Promarker™ platform to look for prognostic markers in the blood that can identify patients at risk of retinopathy, especially sight-threatening retinopathy. The program is again utilising the Fremantle Diabetes Study which provided the rich sample repository that led to PromarkerD.
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Oxidative stress (2-tag)
Status update: Validation studies pending; Commercialisation discussions underway
Proteomics International has formalised its long-term collaboration with The University of Western Australia (UWA) to develop methodology that could become the next generation of medical diagnostic tests. OxiDx Pty Ltd (OxiDx), an incorporated joint venture between the Company and UWA, has been formed to unlock the value from the patented “2-tag” technology which measures the oxidative stress in a system. The patents covering the ‘2-tag’ method are held by Two-Tag Holdings Pty Ltd, a wholly owned subsidiary of OxiDx.
Every person has a base level of oxidative stress at all times – the human body requires oxidative stress to function. However, very high levels of oxidative stress can be dangerous and have been linked to a wide range of chronic diseases including stroke, heart attack, Parkinson’s disease, and muscular dystrophy and muscle damage. The technology has now matured with the 2-tag test demonstrating proof of concept with several publications targeting Duchenne muscular dystrophy and new exploratory work in aquaculture and sports management.
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Oesophageal cancer
Status update: Initial clinical validation study completed
Oesophageal adenocarcinoma is the most common form of oesophageal cancer in Australia. Proteomics International is collaborating with QIMR Berghofer Medical Research Institute (QIMRB) to develop a simple blood test for oesophageal adenocarcinoma.
In June 2022, Proteomics International secured an exclusive worldwide licence from QIMRB to commercialise its biomarkers for oesophageal adenocarcinoma. This followed the successful collaborative initial clinical validation study which identified and validated a panel of biomarkers with the potential to be used as a simple diagnostic test. The results of the study were presented at the International Society for Diseases of the Esophagus 18th World Congress 2022. The data is now being further statistically analysed to optimise the combination of biomarkers to refine the test performance.
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Retinopathy – ARC Centre for Personalised Therapeutics Technologies
Status update: Discovery study ongoing.
Proteomics International is collaborating with the Lions Eye Institute and The University of Western Australia as part of the Australian Research Council Centre for Personalised Therapeutics Technologies, a $3.1 million Federally funded Industrial Transformation Training Centre (ITTC). Proteomics International is working alongside leading university-based researchers to apply the Promarker™ technology to seek a Complementary Diagnostic test to assess treatments for eye disease.
