World first blood test for esophageal cancer shows 94% accuracy in clinical validation study
Esophageal Cancer Diagnostic Delivers Excellent Results
Perth, Sep 23, 2024 AEST (ABN Newswire) - Proteomics International Laboratories Ltd (
ASX:PIQ), a pioneer in predictive diagnostics and precision medicine is pleased to announce outstanding results for its world-first diagnostic blood test to identify esophageal adenocarcinoma, PromarkerEso. The results from the Company's clinical validation study will be presented today at the 20th annual ISDE World Congress for Esophageal Diseases, in Edinburgh, Scotland, held 22-24 September 2024.
- Proteomics International's novel PromarkerEso blood test for esophageal adenocarcinoma shows 94% accuracy in clinical validation study
- Esophageal cancer is the 6th leading cause of cancer-related death, responsible for 1 in 20 cancer-related deaths worldwide, with a five year survival rate of 20% due to late diagnosis
- Results from 165 patient study using the world-first blood test presented at the 20th annual ISDE World Congress for Esophageal Diseases, Edinburgh, Scotland
- Current screening requires a specialist endoscopy procedure and the annual expenditure on treating esophageal cancer in the US is $2.9 billion
- Global health impact: currently 90% of esophageal adenocarcinoma cases go undetected - improved surveillance of at-risk patients using PromarkerEso could enable earlier diagnosis and significantly improve health outcomes
Esophageal adenocarcinoma (EAC) is the predominant type of esophageal cancer in North America, Australia and Europe, and 1-2% of western population are considered at-risk for developing this cancer.
The prevalence of EAC has increased dramatically worldwide, with a six-fold increase over the last 40 years, and it has become the 6th leading cause of cancer-related death and 7th most common cancer, now affecting more than 600,000 people globally each year.
Proteomics International's PromarkerEso blood test utilises glycoprotein biomarkers-'fingerprints' in the blood-to screen for EAC. In this clinical validation study 165 samples (N=66 EAC; N=99 healthy controls) from the Victoria Cancer Biobank were analysed to determine which individuals had EAC and which did not.
The results demonstrated accuracy of 94% and an AUC of 0.93, indicating outstanding diagnostic performance for identifying patients with EAC.
The latest study also included assessment of the refined PromarkerEso test on a previously analysed cohort (Ochsner, USA), which also resulted in strong diagnostic accuracy. These new results build on the Company's previous findings which enabled development of the prototype test [ASX 8 September 2023] and validation of the biomarker panel [ASX 1 February 2024]. In total, nearly 300 samples have now been analysed across three independent patient groups.
Proteomics International Managing Director Dr Richard Lipscombe said the latest results for PromarkerEso represented an exciting breakthrough in identifying this cancer which is notoriously difficult to detect. "We see enormous market potential for a diagnostic test to improve screening and surveillance in at-risk populations. If we can detect esophageal cancer earlier with PromarkerEso then we can help reduce the enormous cost burden of this disease on healthcare systems and save many lives."
Current gold-standard screening for the disease requires a specialist endoscopy, an invasive procedure that costs between GBP1,000-2,000 in the UK, and US$2,750 in the United States, where total expenditure on treating EAC was US$2.9 billion in 2018. In the US 1.5 million endoscopies with biopsy are performed annually in individuals with chronic acid reflux symptoms, but despite this up to 90% of EAC cases continue to go undetected.
The five-year survival rate for EAC is less than 20% because it is frequently diagnosed too late for effective treatment. Men over 50 with history of obesity face elevated risk of EAC, alongside risk factors such as chronic acid reflux, also known as gastroesophageal reflux disease (GERD). Barrett's Esophagus is the only known precursor to EAC, however, 95% of people with Barrett's Esophagus never develop EAC and 95% of patients diagnosed with EAC have no preceding diagnosis of Barrett's Esophagus.
Next Steps
PromarkerEso has patents granted in Europe, China and Australia, with other territories (including the USA) pending. Proteomics International is now preparing to launch PromarkerEso in Australia under ISO 15189 accreditation, targeting Q1 CY25, with other jurisdictions to follow in due course. In the USA, the Company will use its solid understanding of the Laboratory Developed Test (LDT) pathway and the Current Procedural Terminology (CPT) Code (reimbursement) process to accelerate commercialisation. Proteomics International is pursuing go-to-market routes comprising both traditional out-licensing and direct-to-patient strategies.
Presentation details: International Society for Diseases of the Esophagus 20th World Congress 2024, Poster 387 [copy attached; summary below]
Title: Validation of PromarkerEso, a diagnostic blood test to identify esophageal adenocarcinoma Scott Bringans, Jordana Joubert, Iris Wang, Marisa Duong, Gursimran Dhamrit, Richard Lipscombe Proteomics International, Perth, Australia
Summary of the Study
Aim: To assess the performance of the PromarkerEso diagnostic test in patients with esophageal adenocarcinoma (EAC) against healthy controls (HC).
Method: The PromarkerEso test measures the concentration of 4 glycoprotein biomarkers combined with a patient's age and BMI using a bi-model logistic regression approach. Glycoproteins are extracted from a standard blood sample using a lectin pull-down assay and their concentrations determined by mass spectrometry. The statistical model was developed by comparing N=60 EAC patients versus N=43 HC from the PROBE-NET Study, Australia (the 'development cohort').
Diagnostic performance of the model was then tested in two independent cohorts (N=10 EAC, N=14 HC [Ochsner Health System, USA] and N=66 EAC, N=99 HC [Victoria Cancer Biobank, Australia]. The PromarkerEso test results are presented using a "traffic light" system with green (low-), amber (moderate-) or red (high-risk) cut-offs to optimise test performance.
Results: In the primary clinical validation study PromarkerEso showed accuracy of 94% in both determining patients as having EAC, or not having EAC. The area under the receiver operating characteristic curve (AUC) was 0.93, sensitivity 93.1%, with low false positive rate (3.4%), and specificity 96.6% and high "rule-out" capability (NPV= 93.8%).
Conclusion: This clinical validation study of PromarkerEso demonstrated excellent discrimination performance and confirms the diagnostic accuracy of this novel blood test for distinguishing patients with esophageal adenocarcinoma from healthy controls.
About PromarkerEso
PromarkerEso is a novel blood test that measures the concentration of four glycoproteins combined with a patient's age and BMI to produce a risk score. Patients identified as high risk of having EAC are recommended for an endoscopy. Glycoprotein concentrations are measured using a proprietary mass spectrometry-based workflow. PromarkerEso test results are presented using a traffic light approach to optimise test performance with the patient ranked as low- (green), moderate- (amber), or high- (red) risk for EAC. Promarker Eso has patents granted in Europe, China and Australia, with other territories pending.
About the PromarkerTM Platform
Proteomics International's diagnostics development is made possible by the Company's proprietary biomarker discovery platform called Promarker, which searches for protein 'fingerprints' in a sample. This disruptive technology can identify proteins that distinguish between people who have a disease and people who do not, using only a standard blood sample. It is a powerful alternative to genetic testing. The technology is so versatile it can be used to identify fingerprints from any biological source, from wheat seeds to human serum. The Promarker platform was previously used to develop PromarkerD, a world-first predictive test for diabetic kidney disease, that is currently being commercialised. Other tests in development include for endometriosis, asthma & COPD, esophageal cancer, diabetic retinopathy and oxidative stress.
About Proteomics International Laboratories Ltd
Proteomics International Laboratories (ASX:PIQ) is a wholly owned subsidiary and trading name of PILL, a medical technology company at the forefront of predictive diagnostics and bioanalytical 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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