A peer-reviewed study found the assay identified 61.5% of endometriosis cases missed by standard imaging, with a specificity of 97.5% and sensitivity of 80%.
A non-invasive blood-based assay for endometriosis detection has cleared a clinical milestone, with a peer-reviewed validation study now published in the Journal of Minimally Invasive Gynecology. The study, conducted across 11 clinical sites in the United States, Europe, and Hong Kong, evaluated HerAnova Lifesciences’ HerResolve assay in 298 reproductive-age women with suspected endometriosis.
All participants’ HerResolve results were evaluated against concordant laparoscopic findings and histopathological confirmation—the gold standard for endometriosis diagnosis. The assay achieved an area under the curve (AUC) of 0.944 (95% CI: 0.892–0.996), a specificity of 97.5%, and a sensitivity of 80%, according to a release from HerAnova.
The assay identified 61.5% of histologically confirmed endometriosis cases that had been missed by transvaginal ultrasound and/or MRI, according to the release.
How the Assay Works
HerResolve is a multi-omic assay that integrates three serum microRNA biomarkers, three protein biomarkers, one steroid hormone, patient age, and body mass index (BMI) into a random forest artificial intelligence (AI) machine learning algorithm to detect endometriosis.
The model was optimized to maximize specificity in order to minimize unnecessary invasive procedures, according to the release. Performance was validated on an independent cohort with no overlap with the training data.
The assay also demonstrated menstrual phase-independent performance, with an AUC of 0.935 in the proliferative phase and 0.993 in the secretory phase, according to the release.
Contributing institutions included Johns Hopkins School of Medicine, Prince of Wales Hospital of Hong Kong, Kaiser Permanente, and additional academic and community clinical sites across the United States and Europe.
Addressing a Long-Standing Diagnostic Gap
Endometriosis affects approximately 1 in 10 women of reproductive age worldwide, according to research published in the New England Journal of Medicine (Zondervan et al, 2020). Despite its prevalence, the average delay between symptom onset and confirmed diagnosis spans 6 to 11 years, according to the release.
Current gold-standard diagnosis requires laparoscopic surgery—an invasive procedure dependent on surgeon skill. HerResolve was developed to complement existing clinical pathways as a non-invasive triage tool, helping to identify patients who may benefit from further diagnostic evaluation or empirical treatment, reserving surgery for treatment rather than diagnosis, according to the release.
“Endometriosis has long been one of the most underdiagnosed and undertreated conditions in women’s health,” says Farideh Bischoff, PhD, chief medical officer of HerAnova Lifesciences and corresponding author of the study, in a release. “Publication in JMIG represents a meaningful milestone in our mission to bring a reliable, accessible diagnostic tool to the clinicians and patients who need it most. HerResolve was designed to work alongside existing imaging and clinical evaluation, filling a critical gap in non-invasive disease detection.”
The study population reflected real-world diversity, comprising 75.8% White, 9.7% Black, 9.1% Asian, and 5% Non-White/Hispanic participants, according to the release.
Next Steps
A prospective validation study is currently underway in geographically and ethnically diverse populations to further establish the broad clinical utility of HerResolve, according to the release. HerAnova is also pursuing longitudinal analyses to evaluate the assay’s utility in monitoring treatment response.
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