HerAnova™ Publishes Clinical Validation Study of HerResolve™ in the Journal of Minimally Invasive Gynecology

Multi-Center Study Validates Non-Invasive Endometriosis Detection Blood Test, Identifying 61.5% of Cases Missed by Standard Imaging

BOSTON, MA, UNITED STATES, March 9, 2026 /EINPresswire.com/ -- HerAnova™ Lifesciences, a leader in non-invasive diagnostic innovation for endometriosis and infertility in women’s health, today announced the publication of a peer-reviewed clinical validation study of its HerResolve™ assay titled “Non-invasive blood-based detection of endometriosis can improve standard-of-care by facilitating early diagnosis and clinical management among symptomatic women” in the Journal of Minimally Invasive Gynecology (JMIG), the official journal of the American Association of Gynecologic Laparoscopists (AAGL) and one of the leading publications in gynecologic surgery and women's health research. The full study is available here: https://doi.org/10.1016/j.jmig.2026.02.042.

The study reports results from a multi-center case-control study involving 298 reproductive-age women across clinical sites in the United States, Europe, and Hong Kong. All study participants' HerResolve™ results were evaluated against the gold standard of concordant laparoscopic findings and histopathological (tissue) confirmation, the most rigorous diagnostic benchmark available for endometriosis.

Study Highlights

HerResolve™ is a non-invasive, multi-omic blood-based assay that integrates three serum microRNA biomarkers, three protein biomarkers, one steroid hormone, patient age, and body mass index (BMI) into a random forest AI machine learning algorithm to detect endometriosis.

• AUC of 0.944 (95% CI: 0.892–0.996), demonstrating excellent discriminatory power and blood/tissue concordance
• Specificity of 97.5% and sensitivity of 80%, meeting a high bar for a clinical rule-in diagnostic
• Menstrual phase-independent performance: AUC of 0.935 in the proliferative phase and 0.993 in the secretory phase
• 61.5% of histologically confirmed endometriosis cases that were missed by transvaginal ultrasound and/or MRI were successfully identified by HerResolve™

"Endometriosis has long been one of the most underdiagnosed and undertreated conditions in women's health," said Farideh Bischoff, PhD, Chief Medical Officer of HerAnova Lifesciences and corresponding author of the study. "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."

“This publication marks an important step forward for women living with endometriosis who have waited far too long for answers,” said Penny Wan, Chairwoman of HerAnova Lifesciences. “The validation of HerResolve™ in JMIG reinforces the scientific foundation behind our approach and strengthens our commitment to transforming how endometriosis is detected.”

The study enrolled symptomatic women with suspected endometriosis across 11 IRB-approved clinical sites, with concordant histopathological confirmation via laparoscopy serving as ground truth. The study population reflected real-world diversity, comprising 75.8% White, 9.7% Black, 9.1% Asian, and 5% Non-White/Hispanic participants. The machine learning model was optimized to maximize specificity to minimize unnecessary invasive procedures, and performance was independently validated on an independent cohort with no overlap with the training data. 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.

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), yet the average delay between symptom onset and confirmed diagnosis spans 6 to 11 years. Current gold-standard diagnosis requires laparoscopic surgery, an invasive procedure dependent on surgeon skill and not without risk. 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 of endometriosis.

A prospective validation study is currently underway in geographically and ethnically diverse populations to further establish the broad clinical utility of HerResolve™. HerAnova is also pursuing longitudinal analyses to evaluate the assay's utility in monitoring treatment response.

These settings represent a critical point of care where endometriosis frequently intersects with clinical signs and symptoms suggestive of endometriosis—such as pelvic pain and infertility, among others, making HerResolve™ particularly well-suited for integration into existing clinical pathways at fertility and reproductive medicine practices, OBGYN practices and women’s health clinics.

About HerResolve™

HerResolve™ is a multi-omic, blood-based diagnostic assay developed by HerAnova Lifesciences for the detection of endometriosis in symptomatic women of reproductive age. The test integrates quantitative PCR-based microRNA profiling with immunoassay-measured protein and hormone biomarkers, processed through a proprietary machine learning algorithm to generate a binary disease classification. HerResolve™ is the first and only commercially available non-invasive blood test developed to detect endometriosis, currently accessible at select IVF and reproductive medicine centers across the United States.

About HerAnova Lifesciences

HerAnova Lifesciences Inc. is a biotechnology company committed to delivering non-invasive diagnostics and treatments designed to meet critical needs in endometriosis and infertility to improve women’s health. By integrating diagnostics, therapeutics, medical devices, and data analytics, HerAnova aims to provide a one-stop solution for unmet needs in obstetrics and gynecology. Founded in March 2022 in Boston by experienced entrepreneurs and former multinational executives, HerAnova operates on a multinational model for its research, development, and commercialization initiatives. For more information, visit www.HerAnova.com, follow the company on LinkedIn, Facebook, and X, or contact info@heranova.com.

About JMIG – Journal of Minimally Invasive Gynecology

The Journal of Minimally Invasive Gynecology is the official peer-reviewed publication of AAGL (Advancing Minimally Invasive Gynecology Worldwide) and is published by Elsevier. It is an internationally recognized clinical forum for research, clinical opinions, and innovations in gynecologic endoscopy and minimally invasive procedures.

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