Proteomics International Laboratories has achieved a major breakthrough in endometriosis diagnosis with its PromarkerEndo blood test demonstrating nearly 90% accuracy in detecting early-stage disease. The landmark clinical data, presented at the 16th World Congress on Endometriosis in Sydney, represents a significant advancement toward addressing one of women's health's most challenging diagnostic problems.
The study, conducted in collaboration with the Royal Women's Hospital and the University of Melbourne, analyzed 704 plasma samples and validated PromarkerEndo's performance across all stages of endometriosis. The test delivered strong diagnostic performance with area under the curve (AUC) values of 0.89-0.94 for stages I-III, demonstrating particular strength in identifying early-stage disease where intervention can be most effective.
Addressing Critical Diagnostic Delays
Endometriosis affects approximately one in nine women and girls globally, causing severe pelvic pain, painful periods, and infertility. The condition occurs when tissue similar to the uterine lining grows in other parts of the body where it doesn't belong. Currently, diagnosis typically takes an average of seven years and relies on invasive laparoscopy procedures followed by histopathology.
"This is a major step forward in making non-invasive diagnosis of endometriosis a clinical reality," said Dr Richard Lipscombe, Managing Director of Proteomics International. "PromarkerEndo's accuracy and simplicity have the potential to dramatically reduce diagnostic delays and improve outcomes in both general and fertility care."
The test consolidates earlier prototype models into a single, universal diagnostic tool that provides a simple 'traffic light' risk score—low, moderate, or high—indicating the likelihood of endometriosis for any patient. This approach helps guide clinical decision-making without requiring invasive surgical procedures.
Particular Promise in Fertility Care
The diagnostic tool shows particular promise in fertility settings, where undiagnosed endometriosis significantly affects treatment outcomes. The incidence of endometriosis is three times higher among women undergoing fertility treatments, making early detection crucial for optimizing care strategies.
Professor Peter Rogers, Research Director at the Royal Women's Hospital, emphasized the test's potential impact: "A reliable blood test that detects early-stage endometriosis could transform how we manage this condition. PromarkerEndo has the potential to support earlier diagnosis and timely intervention, particularly in fertility settings."
Commercial Pathway and Market Impact
With commercialization and regulatory planning underway, PromarkerEndo is positioned to launch in Australia during Q3 2025. The company plans to leverage its Direct to Consumer framework built for other Promarker tests while simultaneously targeting primary care physicians and clinicians focused on women's health and fertility.
The analytical methodology is being adapted for clinical environment use under the ISO 15189 clinical testing pathway, with regulatory pathway applications, ongoing clinical studies, and partner engagement continuing in parallel. Patents are pending in all major jurisdictions.
Endometriosis costs Australia $9.7 billion annually, highlighting the substantial economic burden alongside the personal impact on affected women. PromarkerEndo represents a first-in-class diagnostic solution targeting this enormous unmet need in the global women's health market.
The breakthrough positions Proteomics International at the forefront of precision diagnostics, with PromarkerEndo representing one of multiple assets in the company's pipeline of innovative diagnostic tools designed to improve disease treatment through earlier, more accurate detection.
