PromarkerEndo Achieves 92% Accuracy in Large-Scale Endometriosis Study

• PromarkerEndo demonstrates high diagnostic accuracy across all endometriosis stages
• Single universal blood test with a 'traffic light' risk score system
• Study of 704 participants validates test performance, including early-stage disease
• Commercial rollout in Australia targeted for Q3 2025
• Potential to replace invasive laparoscopy and improve fertility care outcomes

A New Era in Endometriosis Diagnosis

Proteomics International Laboratories Ltd (ASX: PIQ) has announced a significant milestone in the fight against endometriosis, a chronic condition affecting one in nine women worldwide. At the 16th World Congress on Endometriosis held in Sydney, the company presented compelling new data validating its PromarkerEndo blood test as a highly accurate, non-invasive diagnostic tool. This test consolidates previous prototype models into a single, universal assay that provides a clear 'traffic light' risk score, low, moderate, or high, indicating the likelihood of endometriosis for any patient.

Endometriosis diagnosis has long been hindered by reliance on invasive laparoscopy, often resulting in an average diagnostic delay of seven years. PromarkerEndo’s ability to detect all disease stages, including early-stage endometriosis, offers a transformative alternative that could dramatically shorten this timeline.

Robust Clinical Validation

The validation study involved 704 participants, including confirmed endometriosis cases, symptomatic controls, and general population controls. The test achieved an outstanding area under the curve (AUC) of 0.92, with sensitivity and specificity rates of 83% and 95%, respectively, across all stages. Notably, early-stage disease (stages I–III) detection showed AUCs ranging from 0.89 to 0.94, underscoring the test’s clinical utility where diagnosis is most challenging.

Collaboration with leading institutions such as the Royal Women’s Hospital and the University of Melbourne has reinforced the test’s credibility. Experts like Professor Peter Rogers highlighted the potential for PromarkerEndo to revolutionize clinical management by enabling timely intervention, particularly in fertility care where undiagnosed endometriosis can adversely affect treatment outcomes.

Commercialisation and Market Potential

Proteomics International is preparing for the commercial rollout of PromarkerEndo in Australia by Q3 2025. The launch strategy includes leveraging an existing direct-to-consumer framework alongside targeting primary care physicians and specialists in women’s health and fertility. The test’s non-invasive nature and scalability position it well to address a substantial unmet medical need, with endometriosis costing the Australian economy nearly $10 billion annually.

With patents pending in major jurisdictions and ongoing regulatory and clinical activities, the company is poised to disrupt the current diagnostic paradigm. The PromarkerEndo test not only promises improved patient outcomes but also represents a significant commercial opportunity in the global women’s health diagnostics market.

Looking Ahead

While the test’s predominantly European study population and pending regulatory approvals present challenges, the momentum behind PromarkerEndo is undeniable. As Proteomics International advances toward market introduction, the medical community and investors alike will be watching closely to see how this innovation reshapes endometriosis diagnosis and care pathways.

Bottom Line?

PromarkerEndo’s upcoming launch could redefine endometriosis diagnosis, but regulatory and market adoption hurdles remain.

Questions in the middle?

• How will regulatory approvals progress across different countries beyond Australia?
• What reimbursement pathways will support widespread adoption in healthcare systems?
• Can further validation in more diverse populations confirm the test’s universal applicability?