HerAnova Lifesciences has published a peer-reviewed clinical validation study of its HerResolve blood test for endometriosis in the Journal of Minimally Invasive Gynecology (JMIG), the official journal of the AAGL. The multi-center study found the test identified 61.5% of histologically confirmed endometriosis cases that were missed by standard imaging – transvaginal ultrasound and/or MRI.
HerResolve is a multi-omic blood-based assay that combines three serum microRNA biomarkers, three protein biomarkers, one steroid hormone, patient age, and BMI into a machine learning algorithm to detect endometriosis. The study enrolled 298 reproductive-age women across 11 clinical sites in the U.S., Europe, and Hong Kong, with all results validated against the gold standard of laparoscopic findings with histopathological tissue confirmation.
The headline numbers: An AUC of 0.944, specificity of 97.5%, and sensitivity of 80%. The high specificity is a deliberate design choice – the model was optimized to minimize false positives and reduce unnecessary invasive procedures. Performance was also consistent across menstrual phases, which matters for real-world clinical utility.
“Endometriosis has long been one of the most underdiagnosed and undertreated conditions in women’s health,” said CMO Farideh Bischoff, PhD, corresponding author of the study. “HerResolve was designed to work alongside existing imaging and clinical evaluation, filling a critical gap in non-invasive disease detection.”
Contributing institutions included Johns Hopkins School of Medicine, Prince of Wales Hospital of Hong Kong, and Kaiser Permanente. The study population reflected some demographic diversity: 75.8% white, 9.7% Black, 9.1% Asian, and 5% non-white/Hispanic participants.
The test is currently available at select IVF and reproductive medicine centers across the U.S. and is positioned as a triage tool – helping identify patients who may benefit from further evaluation or empirical treatment rather than replacing surgery entirely, but potentially reserving it for treatment rather than diagnosis.
A prospective validation study is underway in geographically and ethnically diverse populations, and HerAnova is also pursuing longitudinal analyses to evaluate whether the assay can monitor treatment response over time.
Endometriosis affects approximately 1 in 10 women of reproductive age, yet the average diagnostic delay remains 6 to 11 years. The current gold standard – laparoscopic surgery – is invasive, dependent on surgeon skill, and not without risk, making a reliable non-invasive alternative one of the most sought-after tools in women’s health diagnostics.
