PromarkerEso Detects Early Esophageal Adenocarcinoma with 91% Sensitivity in New Study

A Breakthrough in Early Esophageal Cancer Detection

Proteomics International Laboratories Ltd (ASX – PIQ) has announced compelling new clinical validation results for its PromarkerEso blood test, a first-in-class diagnostic tool designed to detect esophageal adenocarcinoma (EAC) at its earliest stages. This form of esophageal cancer, often linked to chronic acid reflux, carries a grim prognosis with a median survival time of less than one year due to late diagnosis. The new data, derived from a 350-participant study, show PromarkerEso can identify stage I and II cancers with high sensitivity, potentially enabling earlier intervention and improved patient outcomes.

Addressing a Critical Unmet Need

Esophageal adenocarcinoma is notoriously difficult to detect early because symptoms often do not appear until the disease has advanced. Current gold-standard screening relies on invasive endoscopy, a procedure that is costly, uncomfortable, and still misses up to 90% of cases. With an estimated 10-20% of Western populations affected by gastroesophageal reflux disease (GERD), a major risk factor for EAC, the need for a more accessible and accurate screening method is urgent. PromarkerEso’s blood test offers a non-invasive alternative that could revolutionize how at-risk patients are monitored.

Robust Clinical Evidence and Performance

The study evaluated two cohorts, comparing healthy controls and patients with various stages of EAC, as well as those with Barrett’s Esophagus with high-grade dysplasia (BE-HGD), a known precursor to cancer. The test demonstrated outstanding diagnostic accuracy, with an area under the curve (AUC) of 0.97 and sensitivity ranging from 81% in stage I to 100% in later stages. Notably, it also showed 93% sensitivity for BE-HGD, highlighting its potential to identify patients before cancer fully develops. These results surpass the performance of many existing cancer biomarkers, including the widely used PSA test for prostate cancer.

How PromarkerEso Works

PromarkerEso combines measurements of four key serum glycoproteins with patient clinical data such as age, sex, and body mass index. This information is processed through a proprietary algorithm that generates a simple 'traffic light' risk score, categorizing individuals as low, moderate, or high risk for EAC. High-risk patients are then recommended for confirmatory endoscopy, potentially reducing unnecessary invasive procedures and focusing resources on those most likely to benefit.

Commercial and Global Health Implications

With patents granted in Europe, China, and Australia, and others pending, PromarkerEso represents a significant commercial opportunity for Proteomics International. The test’s ability to improve early detection could have a profound impact on global health, given the rising incidence of EAC linked to lifestyle factors. The findings have been published in the journal Diseases of the Esophagus and will be presented at the upcoming 21st ISDE World Congress in Brisbane, underscoring the scientific community’s recognition of this advancement.