HerAnova reports strong validation data for endometriosis blood test

HerAnova presented clinical validation data for HerResolve, its blood-based endometriosis test, at the 2026 Endocrine Society Annual Meeting in Chicago. The study found high diagnostic performance and suggested the assay can identify cases missed by ultrasound or MRI, a potential step toward earlier diagnosis for symptomatic women. Why it matters: - Endometriosis affects about 1 in 10 women of reproductive age, but diagnosis often takes seven to 10 years. - HerResolve is designed as a non-invasive triage tool that could reduce reliance on laparoscopic surgery for diagnosis. - Earlier detection can shorten delays to treatment and may help preserve fertility and reduce pain. What happened: - HerAnova Lifesciences presented clinical validation data on HerResolve at the 2026 Endocrine Society Annual Meeting, held June 13-16 in Chicago. - The poster was titled “Non-Invasive Blood-Based Detection of Endometriosis Has Potential to Improve Standard of Care Among Symptomatic Women.” - The research evaluated HerResolve against laparoscopic visualization and histopathological confirmation, the clinical gold standard for endometriosis diagnosis. - The research was also published in the Journal of Minimally Invasive Gynecology, the official journal of the American Association of Gynecologic Laparoscopists, at the published study . The details: - HerResolve is a multi-omic blood test that measures three microRNAs, three protein biomarkers and one steroid hormone biomarker. - The assay uses qPCR and immunoassay technologies. - Patient age and body mass index are also fed into a proprietary AI-driven random forest machine-learning model. - The validation study included 298 women of reproductive age across multiple clinical sites. - Reported performance included an AUC of 0.944, 80% sensitivity and 97.5% specificity. - HerResolve identified 61.5% of true positive cases that were missed by transvaginal ultrasound and/or MRI. - HerAnova says HerResolve is the first and only commercially available non-invasive blood test developed to detect endometriosis, with access at select IVF and reproductive medicine centers in the U.S. - The company says HerResolve is intended to complement existing clinical pathways and help identify patients who may benefit from further diagnostic evaluation or empirical treatment. Between the lines: - The data position blood-based molecular testing as a possible complement to imaging, not a replacement for all existing workups. - The 61.5% figure suggests the assay may add value in patients whose disease is not visible on ultrasound or MRI. - The presentation also fits a broader push in women’s health to move diagnosis earlier and away from invasive procedures. - Farideh Bischoff, HerAnova’s chief medical officer, said the findings could help shorten diagnostic delays and enable earlier treatment interventions. - Penny Wan, HerAnova’s chairwoman, said delayed diagnosis carries consequences including worsening pain, declining fertility and higher healthcare burden. What’s next: - HerAnova says a prospective validation study is underway across geographically and ethnically diverse patient populations. - The company is also running longitudinal analyses to assess whether the assay can help monitor treatment response over time. - HerAnova is continuing engagement with the endocrinology community as it looks to broaden clinical utility and adoption. The bottom line: - HerAnova’s latest data suggest HerResolve could add meaningful diagnostic power for symptomatic women with suspected endometriosis, especially when imaging comes back negative.

Disclaimer: This article was produced by AGP Wire with the assistance of artificial intelligence based on original source content and has been refined to improve clarity, structure, and readability. This content is provided on an “as is” basis. While care has been taken in its preparation, it may contain inaccuracies or omissions, and readers should consult the original source and independently verify key information where appropriate. This content is for informational purposes only and does not constitute legal, financial, investment, or other professional advice.

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