Proteomics International (ASX:PIQ) Secures $500,000 Grant to Advance PromarkerEndo Commercialisation

Proteomics International Laboratories (ASX:PIQ) has secured a $500,000 government grant to accelerate the commercialisation of PromarkerEndo, the world’s first validated blood test for endometriosis diagnosis. This funding from the Western Australian Government’s Future Health Research and Innovation Fund addresses a critical healthcare gap affecting 1 in 9 women globally, where current diagnostic methods require invasive surgery and take an average of 7 years to complete. The Proteomics International PromarkerEndo grant represents a major milestone for the precision diagnostics company, providing non-dilutive funding to support regulatory engagement, marketing development, and partnership establishment ahead of the targeted H2 2025 Australian launch.

Transforming Women’s Healthcare Through Innovation

The WA Government’s Innovation Seed Fund 2024-25 has recognised the urgent need for earlier and simpler endometriosis diagnosis by backing PromarkerEndo. This diagnostic tool utilises Proteomics International’s proprietary Promarker technology platform to detect protein biomarkers in blood samples, providing a simple “traffic light” risk score indicating low, moderate, or high likelihood of endometriosis across all disease stages.

Furthermore, the funding validates the substantial market opportunity in women’s healthcare diagnostics. Endometriosis is a debilitating disease that often begins in adolescence, causing symptoms such as 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 does not belong.

Dr Richard Lipscombe, Managing Director of Proteomics International, commented: “We’re delighted to receive this support from the WA Government to help drive the commercialisation of PromarkerEndo. It highlights the importance of innovation in women’s health and strengthens our push to bring this much-needed diagnostic test to women around the world.”

What Are the Current Challenges in Endometriosis Diagnosis?

Currently, there is no simple test for endometriosis, creating significant healthcare challenges for women worldwide. Diagnosis relies on surgical laparoscopy with biopsy, a procedure that presents substantial barriers to timely detection. The delay is multifactorial, with a key contributor being the reliance on surgery as the gold-standard diagnostic method.

The costs associated with laparoscopic procedures vary considerably. Direct costs range from $2,000 to $15,000, with average out-of-pocket costs reaching $3,690 in Australia for private procedures. In the United States, the financial burden is even more substantial, with average direct costs of US$21,268 and average out-of-pocket costs of US$4,923.

Current Diagnostic Challenges:

• Surgical intervention required for definitive diagnosis
• Average 7-year delay from symptom onset to confirmation
• Substantial direct and indirect healthcare costs
• Limited accessibility to specialised surgical facilities
• Significant impact on quality of life during diagnostic delay
• Economic burden estimated at $9.7 billion per year in Australia alone

In addition, the psychological toll of prolonged diagnostic uncertainty cannot be understated. Women experiencing symptoms often undergo multiple consultations and investigations before receiving confirmation, leading to frustration and anxiety. A non-invasive diagnostic test would represent a major advancement in women’s healthcare delivery.

How Effective Is PromarkerEndo in Detecting Endometriosis?

Recent clinical validation results presented at the World Congress on Endometriosis demonstrated PromarkerEndo’s diagnostic accuracy. The study encompassed 704 participants and achieved 83% sensitivity and 95% specificity across all stages of the disease. These performance metrics position the test as a potentially game-changing diagnostic tool.

The Proteomics International PromarkerEndo grant will support further validation and refinement of this technology. Moreover, the test’s ability to detect endometriosis in early stages represents a significant advancement over current methods, which often fail to identify the condition until it has progressed.

PromarkerEndo Performance Metrics:

The test detects a panel of protein biomarkers—molecular fingerprints—in blood samples to help identify disease presence. This approach provides clinicians with an accessible screening tool for women and girls presenting with symptoms consistent with endometriosis.

PromarkerEndo is designed to support early and accurate diagnosis through a straightforward risk stratification system. The traffic light scoring model—low, moderate, or high—indicates the likelihood of endometriosis for any patient, enabling clinicians to make informed decisions about further investigation and treatment pathways.

What Activities Will the Government Grant Support?

The $500,000 funding will contribute to critical commercialisation activities essential for bringing PromarkerEndo to market. The grant enables Proteomics International to accelerate key development milestones whilst preserving shareholder value through non-dilutive financing.

Regulatory engagement activities will form a cornerstone of the funding allocation. The company will advance discussions with regulatory authorities to ensure PromarkerEndo meets all necessary standards for clinical deployment. Furthermore, analytical methodology is being adapted for use in clinical environments under the ISO15189 clinical testing pathway, ensuring compliance with medical laboratory standards.

Grant Funding Applications:

• Regulatory engagement – Advancing discussions with health authorities
• Marketing development – Building awareness among clinicians and patients
• Partnership establishment – Pursuing licensing opportunities in key markets
• Clinical pathway adaptation – ISO15189 certification processes
• Stakeholder engagement – Connecting with Key Opinion Leaders and advocacy groups

Marketing and partnership development represent another significant focus area. The company continues building awareness of the test with clinicians, Key Opinion Leaders (KOLs), and advocacy groups in response to the upsurge in demand for better endometriosis diagnosis. These efforts will position PromarkerEndo effectively within the healthcare ecosystem prior to commercial launch.

In addition, partnering discussions are advancing in key markets for licensing opportunities in women’s health and fertility sectors. These potential collaborations could expand the test’s reach beyond Australia’s initial launch market, creating multiple revenue streams for Proteomics International.

When Will PromarkerEndo Be Available to Patients?

Proteomics International has outlined a clear commercialisation timeline with H2 2025 targeted for Australian market launch. This timeline leverages the company’s established go-to-market infrastructure from existing Promarker tests, reducing commercialisation risks and accelerating deployment.

The launch strategy will utilise both clinical and digital direct-to-consumer channels in Australia, building on successful approaches implemented for PromarkerD (diabetic kidney disease) and PromarkerEso (oesophageal cancer) diagnostics. This dual-channel approach maximises accessibility whilst engaging both healthcare professionals and patients directly.

Commercialisation Timeline:

Following the Australian launch, the company will pursue international market entry through key partnerships. The Proteomics International PromarkerEndo grant supports foundational activities that will facilitate these subsequent expansion phases.

Moreover, Proteomics International operates a European presence through its Netherlands office, positioned to support continental expansion when appropriate. This existing infrastructure provides a platform for efficient international deployment once initial commercialisation activities are complete.

Why Does Endometriosis Represent Such a Significant Market Opportunity?

Endometriosis affects 1 in 9 women and girls worldwide, creating a substantial addressable market for diagnostic innovations. The condition’s prevalence, combined with current diagnostic inadequacies, establishes compelling market dynamics for solutions like the PromarkerEndo test.

The economic burden of endometriosis extends far beyond direct medical costs. In Australia alone, the total economic impact reaches $9.7 billion per year, encompassing healthcare expenditure, lost productivity, and indirect costs. This substantial figure underscores the societal imperative for improved diagnostic approaches.

Market Opportunity Indicators:

• 1 in 9 women – Global affected population
• $9.7 billion – Annual economic burden in Australia
• 7 years – Average diagnostic delay
• US$21,268 – Average direct costs of laparoscopy in USA
• Multiple symptoms – Pelvic pain, painful periods, infertility

Furthermore, the condition often begins in adolescence, meaning younger patients face extended periods of uncertainty and suffering before diagnosis. Earlier detection through non-invasive testing could dramatically improve outcomes by enabling prompt treatment initiation and preventing disease progression. The substantial costs associated with current surgical diagnostic methods create additional demand for a more accessible and cost-effective solution.

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