Endometriosis affects an estimated 11% of women of reproductive age and is associated with chronic pelvic pain, infertility, and long diagnostic delays due to reliance on invasive laparoscopy. These delays contribute to years of unmanaged symptoms, reduced quality of life, and increased healthcare costs. A non-invasive, accurate test could improve clinical assessment and access to timely care.
Promarker®Endo is a blood-based proteomic test developed to estimate endometriosis risk using a panel of nine plasma protein biomarkers combined with age and BMI. The test generates a risk score (0–100) and classifies individuals as low, moderate, or high risk. The analytical workflow involves immunodepletion of plasma followed by diafiltration, reduction, alkylation and enzymatic digestion before targeted LCMS-MRM analysis. Multiple transitions are monitored for each peptide representing the biomarker proteins, enabling precise and reproducible quantification across samples.
Clinical validation was performed in two phases. Internal validation included subgroup analyses in a well-characterised cohort (n=704) comprising laparoscopically confirmed endometriosis cases (n=436), symptomatic controls (n=126), and general population controls (n=142). PromarkerEndo demonstrated strong accuracy to distinguish endometriosis from controls across all disease stages (AUCs ≥0.89). Performance by hormone use, and age subgroups was also explored. The performance of the test was also explored in an independent cohort.
PromarkerEndo stratifies endometriosis risk across diverse clinical contexts, providing a minimally invasive tool to assist in patient triage and prioritisation for specialist assessment, particularly where access to laparoscopy is limited.