- 01Validated on 400+ Oxford samples.
- 02Sensitivity: 90% for stage IV; 68% across all stages; 71% specificity.
- 03Launch targeted for FY27, subject to approvals.
Proteomics International (ASX: PIQ) has refined and independently validated the model underpinning its PromarkerEndo blood test for the diagnosis of early-stage endometriosis.
The process used more than 400 samples from the University of Oxford in England, following refinement of the initial model developed using samples from The Royal Women’s Hospital in Melbourne.
Independent validation showed the blood test had a sensitivity of 90% for endometriosis stage IV, 84% for stages III to IV, 80% for stages II to IV, and 68% for all stages combined (I to IV), with specificity of 71% across all stage groupings.
PromarkerEndo is a mass spectrometry-based blood test that measures protein biomarkers and combines them with clinical factors in a statistical model to provide a risk profile for endometriosis.
It has been designed to support early clinical assessment of patients suspected of having the chronic inflammatory disease, which affects around one in seven women and currently has an average delay of six to eight years between symptom onset and diagnosis.
Pivotal Validation Milestone
Chief executive officer David Morris said the independent validation was a pivotal milestone for the company as it works to bring its three core Promarker tests — PromarkerD for diabetic kidney disease, PromarketEso for esophageal cancer, and PromarkerEndo — to market.
“Our objective with this test was to give clinicians additional information to support the assessment and management of patients with suspected endometriosis and, ultimately, to improve the diagnostic journey for women affected by the disease,” he said.
Proteomics clinical pathologist Dr Johan Conradie added that he looked forward to seeing how the test could be integrated into existing clinical pathways to support earlier diagnosis of endometriosis and improve patient care.
PromarkerEndo has been earmarked for commercial availability during the 2027 financial year, subject to clinical deployment and regulatory requirements.
Huge Economic Burden
Endometriosis occurs when the tissue characteristic of the uterine lining grows outside of the uterus, causing inflammation, scarring, persistent pelvic pain, painful periods, and fertility difficulties.
The Australian health system spent $293 million on diagnosis and treatment in 2022-23 (equating to more than double that spent in 2013-2014), with the rates of hospitalisation due to endometriosis reported to have risen by 23% over the last decade.
PromarkerEndo was developed to provide additional blood-based information to help clinicians assess the likelihood of endometriosis and prioritise further investigation.
Proteomics recently received a notice of acceptance from IP Australia for a PromarkerEndo patent application, providing it with patent protection in Australia through to March 2041 and adding to patents already secured in the US and Japan.
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