Breakthrough in Endometriosis Diagnosis: Proteomics International Set to Launch Innovative Test in Australia and the US

Proteomics International (PIL), a pioneering diagnostics firm based in Nedlands, Australia, is gearing up for the launch of its groundbreaking proteomic test for endometriosis in the first half of this year, with plans to extend its availability to the United States shortly thereafter.

Understanding Endometriosis

Endometriosis, a debilitating condition that affects around 10% of women of reproductive age, is characterized by the growth of uterine-like tissue outside the uterus, leading to severe pelvic pain, heavy menstrual periods, and fertility complications. Astonishingly, current diagnostic methods can take an average of 7.5 years, as symptoms often mimic those of other conditions, making it a nightmare for many women seeking answers. Richard Lipscombe, the managing director of PIL, acknowledges the hesitance from physicians to resort to the invasive laparoscopic surgery often required for a definitive diagnosis, highlighting the risks tied to unnecessary procedures.

A Noninvasive Solution

"Our noninvasive test will provide a much-needed solution for symptomatic women, potentially identifying their risk for endometriosis without the need for surgery," Lipscombe stated, shedding light on the potential to streamline and expedite the diagnostic process.

The PromarkerEndo Test

The PromarkerEndo test, developed by PIL, evaluates levels of 10 specific plasma proteins to assess the likelihood of endometriosis presence. A recent study published in the journal *Human Reproduction* by PIL researchers in collaboration with the University of Melbourne details the identification of these crucial biomarkers through an intricate process involving mass spectrometry.

Research Breakthroughs

In their research, the scientists initially identified 48 potential protein markers from various samples, including healthy individuals and those showing symptoms of endometriosis. They refined this list to 51 by incorporating additional proteins from scientific literature, ultimately forming targeted panels dedicated to diagnosing the condition. The results were impressive; the most effective model demonstrated an outstanding accuracy ranging from 85.2% for stage I endometriosis to a staggering 99.7% for stage IV.

PIL's Future Plans

"This research represents a pivotal step in offering an effective diagnostic tool," Lipscombe emphasized. "It gives us the credible evidence needed to transition from lab-testing to a clinical-grade diagnostic."

Compliance and Clinical Studies

Currently, PIL is diligently working toward ensuring compliance with clinical standards, specifically ISO 15189 and CLIA, with expectations to finalize this in the next three to six months. Following this, the company is set to assess the test further in various cohorts, including a partnership with the University of Oxford providing around 600 plasma samples for the next stage of clinical research.

Competitive Landscape

The landscape for endometriosis testing is rapidly evolving, with several other companies, including Aspira Women's Health and Nura Health, also developing their own diagnostic solutions. Aspira, for instance, has secured significant funding for its Endoinform blood test, while French company Ziwig offers a saliva test that is already available in Europe.

Further Developments at PIL

In tandem with these advancements, PIL is pushing forward with its PromarkerD test for diabetic kidney disease, riding high off a recent US licensing agreement with Sonic Healthcare USA and Medicare's decision to reimburse the test at a rate of $390.75. However, the partnership faced challenges and was recently terminated due to unmet commercial milestones.

Looking Ahead

As PIL navigates these hurdles, it eyes a robust future in both endometriosis and diabetic kidney disease diagnostics, aiming to usher in significant changes to how these conditions are understood and managed.

Conclusion

In summary, the upcoming launches of the PromarkerEndo test could redefine the endometriosis diagnostic landscape, providing women with quicker answers, easing their journey toward management and treatment, and potentially saving lives.