Novel blood test could diagnose endometriosis

Proteomics International Laboratories has announced promising results regarding a potential world-first blood test for diagnosing endometriosis, which it presented at the 70th Annual Meeting of the Society for Reproductive Investigation (SRI) in Brisbane from 21–25 March.

Endometriosis is a common and painful disease that affects one in nine women and girls, often starting in teenagers. It occurs when tissue similar to the lining of the uterus grows in other parts of the body where it does not belong, which can cause pain and infertility.

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. On average, it takes women 7.5 years to be diagnosed with the condition, which costs Australia $9.7 billion each year.

Proteomics International’s endometriosis diagnostic test, developed in collaboration with The Royal Women’s Hospital and The University of Melbourne, works by measuring the concentration of biomarkers in the blood that are associated with endometriosis. The company has identified a panel of 14 biomarkers that change concentration as the severity of endometriosis increases and has built a series of statistical models using different combinations of these biomarkers to diagnose disease. Analysis shows these biomarkers all relate to biological pathways that could be linked to the unwanted tissue growth that occurs in endometriosis.

Research presented at the conference shows Proteomics International’s preferred test prototype correctly identifying up to 90% of patients when comparing moderate or severe endometriosis to symptomatic controls (no endometriosis) in a 901-person study. Significantly, it also suggests that some people may currently be misdiagnosed in the early stages of the disease.

“We think this is possible because during a laparoscopy it can be difficult for surgeons to definitively detect and confirm the small lesions that occur when uterine tissue starts growing in the wrong place,” explained Proteomics International Managing Director Dr Richard Lipscombe.

Proteomics International’s preferred diagnostic model targets a potential early screening test to rule in or rule out the need for invasive surgery by distinguishing symptomatic controls from moderate and severe endometriosis. It employs the ‘traffic light’ scoring system developed for the company’s test for predicting the onset of diabetic kidney disease, PromarkerD, which is currently rolling out in the USA.

Lipscombe said Proteomics International is seeking to study more people in the early stages of endometriosis or with symptoms and to look more closely at their existing diagnosis. In the meantime, the company has filed patents in all major jurisdictions for a method to measure a panel of protein biomarkers to determine whether a subject has endometriosis.

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