The Promarker™ Pipeline

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 and diagnostic model completed; accessing additional samples for independent validation.

Research into Proteomics International’s potential world-first blood test for endometriosis showed a strong diagnostic performance of the test. The Company’s preferred prototype correctly identified up to 90 per cent of patients when comparing moderate or severe endometriosis to symptomatic controls (no endometriosis) in a study of 901 participants. The endometriosis study was conducted in collaboration with the Royal Women’s Hospital and the University of Melbourne.

Proteomics International’s results also suggest the current gold standard for diagnosis – an invasive surgical procedure – may be misdiagnosing some patients, particularly in the early stages of endometriosis.

Research findings related to the test were presented at several conferences during the year, including:
• Fertility Society of Australia and New Zealand Annual Conference (FSANZ 2022) in Sydney, July 2022
• 70th Annual Meeting of the International Society for Reproductive Investigation (SRI) in Brisbane, March 2023
• 15th World Congress on Endometriosis in Edinburgh, May 2023

Proteomics International is now targeting confirming the clinical performance and clinical utility of the test in independent patient cohorts, and accelerating pathways to commercialisation of the biomarker panel as a new diagnostic screening test for endometriosis.

 

Oesophageal cancer

Status update: Clinical validation study completed; statistical modelling ongoing; accessing additional samples for independent validation.

Research into the Company’s prototype diagnostic test for oesophageal adenocarcinoma showed strong diagnostic performance, with the test detecting up to 90% of people with the frequently fatal condition. The results were presented at the 18th World Congress for Esophageal Diseases in Tokyo, Japan, 26-28 September 2022.

Oesophageal adenocarcinoma is the most common form of oesophageal cancer and is an area of significant unmet medical need, with current screening requiring a specialist endoscopy procedure that costs US$2,750 per patient in the United States. The results represent an exciting milestone in the development of a potential new, accurate, and easy to use blood test for oesophageal adenocarcinoma. To enhance the accuracy and clinical utility of its test the Company is currently undertaking additional data analysis.

 

Oxidative stress (2-tag)

Status update: Proof-of-concept completed; validation studies commencing.

Proteomics International announced the spin-off of an independent business to commercialise technology for measuring oxidative stress testing technology developed in collaboration with The University of Western Australia. The new incorporated joint venture – OxiDx Pty Ltd – is focussing on developing innovative medical diagnostic products using the patented ‘2-tag’ measure for oxidative stress.

Oxidative stress has been implicated in many chronic diseases, and the ‘2-tag’ method could be part of the next generation of medical diagnostic tests. The technology has several target applications, including chronic fatigue, muscular dystrophy, high-performance athletes and the horse racing industry.

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Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Status update: Proof-of-concept study completed; patent application filed; clinical validation ongoing.

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).

An initial 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. A patent application on methods for diagnosing airway disease has been filed. Potential biomarkers from this study are now being validated in a larger clinical cohort. The results of this validation will refine the panel of biomarkers into a potential new blood test for diagnosing obstructive airway disease.

 

Plant Dieback (Phytophthora cinnamomi)

Status update: Discovery phase successfully completed; validation phase ongoing.

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. Initial investigations focused on proteomic analysis (determining the protein maps) of the life stages of the organism and how it infects its host. These maps provided a blueprint of what proteins were present throughout the life cycle of the organism.

Biomarkers for identifying plant dieback have been discovered, with current experiments determining their detection level in ‘real life’ samples of infected plant root. This opens the way for developing a simple field 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.

Discovery experiments have yielded potential biomarkers for the early diagnosis of retinopathy. The next stage is to verify these biomarkers in a larger cohort set.

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