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 2024 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 technology has broad applicability and is being used to produce multiple new diagnostic tests to address significant unmet medical and commercial needs associated with the following diseases:.
Diabetic Kidney Disease – PromarkerD
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 – PromarkerEndo
Status update: The Company is pursuing multiple avenues to ensure its novel blood test for endometriosis is commercial ready via a single or hybrid Go-to-Market strategy (see page 10 in the 2024 Annual Report).
Activities include:
• Diagnostic algorithm is being refined and the ‘traffic light’ scoring system incorporated
• Analysis of samples from the University of Oxford is ongoing
• Development of the PromarkerEndo Hub for reporting patient results has commenced
• Analytical methodology is being refined for use in a clinical environment
• Partnering discussions are advancing
Endometriosis is a common and painful disease that affects approximately 1 in 9 women and girls, often starting in teenagers. It occurs when tissue similar to the lining of the uterus grows in other parts of the body where it does not belong. At the moment, there is no simple way to test for the condition, which can cause pain and infertility, and costs Australia $9.7 billion each year.
Results validate biomarkers for PromarkerEndo test for endometriosis
In February 2024, Proteomics International achieved a critical milestone in the development of its potential breakthrough blood test for endometriosis, with the confirmation of the clinical performance of the PromarkerEndo biomarkers in an independent patient cohort. The study was performed in conjunction with the St John of God Subiaco Hospital Gynaecological Cancer Research Group [ASX: 30 June 2022], and presented at the 29th Annual Lorne Proteomics Symposium, the annual conference of the Australasian Proteomics Society.
Agreement signed with University of Oxford to further validate PromarkerEndo
In March 2024, Proteomics International announced it signed a Material Transfer Agreement with the globally respected University of Oxford to acquire approximately 600 patient plasma samples for its endometriosis study.
The analysis of the University of Oxford samples is expected to be completed in 2024. In parallel, the Company has also commenced the process of streamlining PromarkerEndo to produce a test suitable for clinical laboratory use, and is targeting market access pathways that use the ISO 15189 international standard or the US Laboratory Developed Test (LDT) for CLIA certified clinical laboratories.
Key Opinion Leader (KOL) engagement and awareness
As part of Endometriosis Awareness Month in March 2024, Proteomics International hosted a panel discussion featuring key experts in the endometriosis sector. The discussion brought together clinicians, researchers, patients and community members to shed light on the challenges, successes, strategies, and future developments in diagnosing endometriosis. Such activities serve to meet the Company’s objective of engaging with potential users of its technology to drive awareness, adoption and uptake of its novel diagnostic tests.
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Oesophageal cancer – PromarkerEso
Status update: The Company is pursuing multiple avenues to ensure its novel blood test for esophageal cancer is commercial ready via a single or hybrid Go-to-Market strategy (see page 10 in the 2024 Annual Report).
Activities include:
• Diagnostic algorithm is being refined and the ‘traffic light’ scoring system incorporated
• Analysis of samples from the Victorian Biobank is ongoing
• Development of the PromarkerEso Hub for reporting patient results has commenced
• Analytical methodology has been refined for use in a clinical environment
• Clinical utility study framework is being finalised
• Results are being prepared for presentation at the 20th World Congress of the International Society for Diseases of the Esophagus
Esophageal adenocarcinoma is the most common form of esophageal 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 overall five-year survival rate for this cancer is less than 20 per cent, and 1 in 20 cancer deaths worldwide in 2018 were attributed to esophageal cancer. An estimated 10-15% of patients with chronic acid reflux develop Barrett’s esophagus, a condition which is asymptomatic and affects 1-2% of Western populations.
Results validate biomarkers for PromarkerEso test for esophageal adenocarcinoma
In February 2024, Proteomics International achieved a critical milestone in the development of its potential breakthrough blood test for esophageal adenocarcinoma, with the confirmation of the clinical performance of the PromarkerEso biomarkers in a second independent patient cohort. The study was performed in conjunction with the Victorian Cancer Biobank (see below), and presented at the 29th Annual Lorne Proteomics Symposium, the annual conference of the Australasian Proteomics Society.
In July 2023, Proteomics International signed an agreement to access 350 additional patient samples from the Victorian Cancer Biobank. The cohort comprised blood samples from esophageal and other selected cancer patients, and will be used for external validation of the accuracy of the prototype oesophageal cancer test.
Showcase at International Conference
In September 2023, Proteomics International presented the latest results for PromarkerEso at the 19th ISDE World Congress for Esophageal Diseases in Toronto, Canada. The prototype test showed strong discrimination at early and late stages of the disease, correctly identifying 89% of patients with esophageal adenocarcinoma and 92% of patients without the condition.
The conference presentation built on earlier work which identified and validated a panel of glycoprotein biomarkers using 300 samples from two independent clinical cohorts [ASX: 27 September 2022]. The World Congress also enabled engagement with several global KOLs in the field, which is critical to the future broad adoption of the test.
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Oxidative stress (2-tag) – OxiDx
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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Diabetic Kidney Disease in type 1 diabetes – PromarkerD
Status update: Clinical validation study being finalised.
Following the success of the diabetic kidney disease project targeting type 2 diabetes, Proteomics International has extended its collaboration agreement with The University of Western Australia to seek early biomarkers for DKD in type 1 diabetes.
Proteomics International previously announced it has become an industry partner to the Australian Centre for Accelerating Diabetes Innovations (ACADI) [ASX: 27 January 2022]. The Centre combines diabetes expertise from across Australia and aims at improving the lives of people living with diabetes. The Company will also explore the applicability of PromarkerD to patients from ACADI with type 1 diabetes.
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Asthma and Chronic Obstructive Pulmonary Disease (COPD)
Status update: Proof-of-concept study completed; patent application filed; clinical validation on-hold.
Proteomics International has previously 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.
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Plant Dieback (Phytophthora cinnamomi)
Status update: Potential diagnostic test identified; findings published. Economic benefit study required for commercialisation.
In May 2024, Proteomics International announced it had collaborated successfully with the Curtin University’s Centre for Crop and Disease Management to make an important breakthrough in understanding how dieback impacts plants, with the findings published in the Journal of Proteomics.
Phytophthora dieback is a plant disease that can spread rapidly and have a significant impact on native vegetation and premium crops such as avocados. Phytophthora cinnamomic is considered the species of dieback that has the greatest impact on biodiversity, and also causes tens of millions of dollars of crop losses annually in Australia alone.
A greater understanding of dieback and its mode of actions means Proteomics International is better equipped to develop diagnostic tools to accurately detect dieback in the soil, which would be of significant benefit to the agricultural industry, and others.
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Diabetic Retinopathy
Status update: Discovery study complete. Proof-of-concept study 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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Diabetic neuropathy
Status update: Discovery study commenced.
Following the partnership with ACADI (see above) Proteomics International has added a new R&D program to investigate predictive biomarkers for diabetic neuropathy.
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Giardia (causing gastroenteritis)
Status update: Project suspended.
Giardia is a leading cause of infectious gastroenteritis worldwide and one of the most common parasitic human diseases. Proteomics International has identified strain specific Giardia targets however further work is required to develop an assay for clinical use. The project is currently on hold pending a review of its commercial and technical viability.
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