FCO-56 A novel biomarker for the non-invasive detection of endometriosis: preliminary results from a prospective observational study.
Introduction
Endometriosis affects 190 million women worldwide, yet there are no accurate non-invasive diagnostic tests contributing to the average 8-year diagnostic delay. EnBi1 has been identified as a candidate urine biomarker and this study aims to assess its diagnostic accuracy.
Methods
Patients with symptoms of endometriosis undergoing elective laparoscopy were recruited into this prospective observational study. Patients were allocated into deep (DE), superficial (SE) or no endometriosis groups (SC) by a BSGE-accredited endometriosis surgeon. Healthy volunteers (HV) were carefully screened and recruited. Urinary EnBi1 expression was determined by ELISA (Abbexa) and normalised to specific gravity.
Results
190 participant samples were analysed: 152 women with endometriosis, 19 symptomatic controls and 19 healthy volunteers. Mean age of participants was 33 (range 19-49) and BMI 27 (range 16-44). There was no difference between groups for age (p=0.15) or BMI (p=0.07). EnBi1 was detectable in every sample with a mean level of 13.8 ng/ml (range 0.25-54.22).
The highest urinary EnBi1 levels were seen in HV, with significantly lower levels in women with endometriosis compared to controls (KW p=0.008). In participants not taking hormonal contraception EnBi1 levels are significantly lower in participants with DE compared to SE (MW p=0.02), SC (MW p=0.05) and HV (MW p<0.0001). There was no association with EnBi1 concentration and either age or BMI.
Conclusion
EnBi1 is detectable in the urine of reproductive age women and is a promising marker of deep endometriosis. Recruitment is ongoing to investigate its clinical utility together with its association with menstrual cycle and hormonal medications.