PromarkerEndo advances toward clinical use with real-world validation data presented at World Congress on Endometriosis
PromarkerEndo Latest Results Presented at World Congress
Perth, May 26, 2025 AEST (ABN Newswire) - Proteomics International Laboratories Ltd (
ASX:PIQ) (PIQLF:OTCMKTS), a pioneer in precision diagnostics, is pleased to announce another milestone in the development of its PromarkerEndo diagnostic test for endometriosis. New data presented at the prestigious World Congress on Endometriosis, held in Sydney, Australia, 21-24 May, confirms that PromarkerEndo is fast transitioning from prototype to a clinically viable, real-world solution for non-invasive diagnosis of endometriosis.
- Landmark results as PromarkerEndo blood test demonstrates high diagnostic accuracy across all stages of endometriosis using a single universal test
- The results consolidate earlier prototype models into a universal test with a simple 'traffic light' risk score - low, moderate, or high - indicating the likelihood of endometriosis for any patient
- PromarkerEndo test now offers a real-world solution for patients with symptoms or considering fertility treatments by diagnosing early-stage endometriosis
- Results from a study of 704 participants presented over the weekend at 16th World Congress on Endometriosis, Sydney, Australia
- Launch plans underway with commercial rollout of PromarkerEndo in Australia set for Q3 CY25
- PromarkerEndo targets a huge unmet need in diagnostics and fertility care - enormous market potential with 1 in 9 women affected - currently diagnosis typically takes an average of 7 years
Endometriosis, a chronic condition affecting one in nine women and girls worldwide, often takes an average of seven years to diagnose due to the reliance on invasive laparoscopy. The latest results advance the breakthrough study published last December [ASX 30 December 2024] by consolidating earlier prototype models into a single, universal diagnostic test. PromarkerEndo now provides a clear and simple 'traffic light' risk score - low, moderate, or high - indicating the likelihood of endometriosis for any patient, helping guide clinical decision-making.
The results, derived from the analysis of 704 plasma samples validate the performance of the PromarkerEndo test in detecting all stages of endometriosis with high accuracy. Proteomics International scientists, in collaboration with the Royal Women's Hospital and the University of Melbourne, compared cases of endometriosis, general population controls, and symptomatic controls. The test also delivered strong and improved diagnostic performance for early-stage disease (AUCs 0.89 - 0.94 for stages I-III), which is critical for real-world use.
PromarkerEndo is now positioned as a non-invasive, scalable tool for earlier diagnosis of endometriosis, potentially eliminating the current reliance on invasive surgical procedures such as laparoscopy.
Proteomics International Managing Director Dr Richard Lipscombe said, "this is a major step forward in making non-invasive endometriosis diagnosis a reality. PromarkerEndo has the potential to dramatically reduce diagnostic delays with its simplicity, accuracy, and broad applicability - including in fertility care. The advances support our commercialisation strategy and reinforce the potential for PromarkerEndo to become a standard part of the clinical diagnostic pathway."
The findings were presented to leading clinicians and researchers at the 16th World Congress on Endometriosis on Saturday, highlighting strong global interest in the test's future adoption. The test is also being explored for its potential application in fertility settings, where undiagnosed endometriosis is knownto affect treatment outcomes and is three times more common among women undergoing IVF treatment.
Professor Peter Rogers, endometriosis researcher and Research Director at the Royal Women's Hospital, commented, "a simple, reliable blood test that can detect early-stage endometriosis could transform how we manage this condition. PromarkerEndo has the potential to reduce diagnostic delays and support timely intervention, especially in fertility cases where endometriosis often goes undiagnosed."
Endometriosis is a common and painful disease that occurs when tissue similar to the lining of the uterus grows in other parts of the body where it does not belong. Endometriosis severity is classified by the American Society for Reproductive Medicine as stage I/minimal, stage II/mild, stage III/moderate and stage IV/severe.
Currently, there is no simple way to test for endometriosis, which can cause pain and infertility, and costs Australia $9.7 billion each year. The current gold standard for detection is an invasive laparoscopy followed by histopathology, a surgical procedure where a camera is inserted into the pelvis through a small cut in the abdominal wall and then a biopsy is taken for analysis.
Next Steps:
- PromarkerEndo commercialisation planning underway with target launch date Q3 CY25 in Australia.
- The launch will leverage the Direct to Consumer (DTC) framework built for other Promarker tests, and in parallel target primary care (GP's) and clinicians focused on women's health and fertility.
- Analytical methodology is being adapted for use in a clinical environment under the ISO 15189 (clinical testing) pathway.
- Regulatory pathway applications, ongoing clinical studies and partner engagement continue in parallel.
- Patents pending in all major jurisdictions.
- Proteomics International will provide further updates as it moves toward bringing PromarkerEndo to market.
PromarkerEndo is one of multiple assets in Proteomics International's pipeline of precision diagnostics and represents a substantial commercial opportunity in the global women's health market.
To view the Summary of the Study, please visit:
https://abnnewswire.net/lnk/3AM883F4
About Proteomics International Laboratories Ltd
Proteomics International Laboratories (ASX:PIQ) is a wholly owned subsidiary and trading name of PILL, a medical technology company at the forefront of predictive diagnostics and bioanalytical services. The Company specialises in the area of proteomics - the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.
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