Proteomics International Laboratories’ (ASX: PIQ) latest results for its novel blood test for oesophageal adenocarcinoma will be presented at the 19th ISDE World Congress for Esophageal Diseases in Toronto, Canada.
The conference presentation builds upon earlier work which identified and validated a panel of glycoprotein biomarkers using 300 samples from two independent clinical cohorts [ASX: 27 September 2022].
Oesophageal adenocarcinoma is the most common form of oesophageal cancer with a five-year survival rate of approximately 20%. Oesophageal cancer and its pre-malignant condition Barrett’s oesophagus can develop from chronic acid reflux. One in twenty cancer deaths worldwide in 2018 were attributed to oesophageal cancer.
Proteomics International Managing Director Dr Richard Lipscombe said the prototype test, named PromarkerEso, was now showing strong discrimination at early and late stages of the disease.
“We’ve refined our diagnostic models to correctly identify 89% of patients with oesophageal adenocarcinoma and 92% of patients without the disease. This means we could have a simple blood test to determine who would benefit from an endoscopy. We believe that such a test would garner significant clinical and commercial interest should it be further validated.”
Screening for oesophageal adenocarcinoma currently requires a specialist endoscopy procedure that costs US$2,750 per patient in the United States, where the total expenditure on treating oesophageal cancer was $2.9 billion in 20183. This cancer represents an area of significant unmet medical need, and the Company believes there is large market potential for a simple diagnostic test.
The new results apply Proteomics International’s ‘traffic light’ scoring system to categorise patients as green (low risk), amber (moderate risk) or red (high risk) for oesophageal adenocarcinoma. The results also suggest some individuals may have been misdiagnosed, although further work is required to confirm this.
Proteomics International’s test uses biomarkers – protein ‘fingerprints’ in the blood – to diagnose both oesophageal adenocarcinoma and Barrett’s oesophagus. An estimated 10-15% of patients with chronic acid reflux develop Barrett’s oesophagus, a condition which is asymptomatic and affects 1-2% of Western populations. People with Barrett’s oesophagus are much more likely to get oesophageal adenocarcinoma, and are advised to get regular endoscopies to screen for oesophageal cancer.
Engaging with Key Opinion Leaders (KOLs) who could guide early adoption of PromarkerEso is an important objective for the company in attending the conference. These potential relationships would build upon Proteomics International’s recent agreement to access 350 additional patient samples from the Victorian Cancer Biobank.
The cohort comprises blood samples from oesophageal and other selected cancer patients. These samples will be used for external validation of the accuracy of the company’s current prototype oesophageal cancer test, with results expected early next year.
Dr Lipscombe said the next steps in commercialising the PromarkerEso test are to:
* streamline the biomarker measurements to produce a test suitable for the US Laboratory
Developed Test (LDT) pathway via CLIA certified clinical laboratories;
* confirm the clinical performance of the test in an additional independent patient cohort; and
* conduct formal Economic Health Benefit Modelling and Clinical Utility Studies to demonstrate how the new test could significantly change doctors’ treatment decisions and improve outcomes for patients and healthcare systems.
The Company anticipates that these steps will be completed over the next nine months.
