Proteomics International Laboratories Ltd (ASX:PIQ) has announced promising results for its novel blood test, PromarkerEso, designed for the detection of esophageal adenocarcinoma (EAC). The clinical validation study, presented at the 20th annual ISDE World Congress for Esophageal Diseases, demonstrated 94% accuracy in identifying EAC using the world-first diagnostic blood test.
Clinical Validation Results
The study, involving 165 patient samples (66 EAC cases and 99 healthy controls) from the Victoria Cancer Biobank, showcased PromarkerEso's ability to distinguish between individuals with and without EAC. The test achieved an area under the curve (AUC) of 0.93, indicating strong diagnostic performance. These findings build upon previous studies, bringing the total sample size analyzed to nearly 300 across three independent patient groups.
Addressing a Critical Unmet Need
Esophageal cancer is the sixth leading cause of cancer-related deaths globally, with a five-year survival rate of only 20% due to late diagnosis. Current screening methods rely on specialist endoscopy, an invasive and costly procedure. In the US, approximately 1.5 million endoscopies with biopsy are performed annually for individuals with chronic acid reflux symptoms, yet up to 90% of EAC cases remain undetected. The annual expenditure on treating EAC in the US is $2.9 billion.
How PromarkerEso Works
PromarkerEso utilizes glycoprotein biomarkers—'fingerprints' in the blood—to screen for EAC. The test measures the concentration of four glycoproteins, combined with a patient's age and BMI, to generate a risk score. Results are presented using a traffic light system, categorizing patients as low (green), moderate (amber), or high (red) risk for EAC. Patients identified as high risk are recommended for an endoscopy.
Management Perspective
"The latest results for PromarkerEso represent an exciting breakthrough in identifying this cancer which is notoriously difficult to detect," said Proteomics International Managing Director Dr. Richard Lipscombe. "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."
Next Steps for Commercialization
With patents secured in Europe, China, and Australia, and applications pending in other territories including the USA, Proteomics International is preparing to launch PromarkerEso in Australia under ISO 15189 accreditation, targeting Q1 CY25. The company is also pursuing commercialization strategies in the USA, leveraging its understanding of the Laboratory Developed Test (LDT) pathway and the Current Procedural Terminology (CPT) Code reimbursement process.
