First real-world data demonstrates consistent test performance across diverse clinical settings and reinforces clinical utility in aiding diagnosis
BOSTON, MA, UNITED STATES, July 28, 2026 /EINPresswire.com/ — HerAnova™ Lifesciences, a leading life sciences company dedicated to advancing innovative solutions for endometriosis, infertility and other critical unmet needs in women’s health, today announced the presentation of new real-world clinical data evaluating HerResolve™, its multi-omic blood-based test designed to aid in the diagnosis of endometriosis in symptomatic women. The findings will be presented in a poster presentation at the 2026 Midwest Reproductive Annual Symposium, taking place July 26–29, 2026, in Chicago, Illinois.
The presentation, entitled Ongoing Evaluation of Real-World Clinical Performance of a Multi-Omic Blood-Based Molecular Test (HerResolve™) for Detection of Endometriosis in Symptomatic Women, analyzed 197 commercial cases from women referred for HerResolve™ testing due to signs and symptoms associated with endometriosis, including unexplained infertility, pelvic pain and/or abnormal uterine bleeding.
“These findings support the consistency of the multi-omic model and the feasibility of HerResolve™ as a non-invasive adjunct in the diagnostic pathway,” said Farideh Bischoff, Ph.D., Chief Medical Officer of HerAnova Lifesciences. “We look forward to expanding the evidence base for HerResolve™ as we continue our larger performance study for regulatory submission as a noninvasive aid in diagnosing endometriosis among symptomatic women.”
Key findings from the presentation include:
– 104 cases (53%) were classified as DETECTED by HerResolve™, while 93 cases (47%) were classified as NOT DETECTED
– Patients had a mean and median age of 35 years
– Patients were referred for testing primarily due to unexplained infertility, pelvic pain, and/or abnormal uterine bleeding
– Testing was ordered by multiple providers, with five centers accounting for the majority of cases, reflecting broad early adoption across diverse clinical practices
– Algorithm output probabilities demonstrated clear stratification between the DETECTED and NOT DETECTED groups
– High-probability outputs above 0.9 were frequently associated with DETECTED classifications, supporting internal model consistency
“Real-world data is critical as we continue to advance HerResolve™ toward broader clinical adoption,” said Penny Wan, Chairwoman of HerAnova Lifesciences. “For too many women, the journey to an endometriosis diagnosis can take as long as a decade, delaying access to appropriate care and answers. These data reinforce the potential of HerResolve™ to provide clinicians with meaningful insights earlier in the diagnostic process, helping more women receive the information they need to better understand their symptoms and take the next steps toward care. We remain committed to advancing innovative noninvasive solutions that can address the limitations of current standard of care and transform the way endometriosis is identified and managed.”
The abstract is published in the North American Proceedings in Gynecology and Obstetrics –Supplemental: https://doi.org/10.54053/001c.165357 and builds on the clinical validation data recently published in the Journal of Minimally Invasive Gynecology (JMIG), the official journal of the American Association of Gynecologic Laparoscopists. The published study demonstrated an AUC/accuracy of 97.4%, 80% sensitivity, and 97.5% specificity: https://doi.org/10.1016/j.jmig.2026.02.042.
About HerResolve™
HerResolve™ is a multi-omic, blood-based diagnostic assay developed by HerAnova Lifesciences to aid in the diagnosis of endometriosis in symptomatic women of reproductive age. The test integrates microRNA, protein, and a hormone biomarker analyzed through a proprietary machine learning framework. 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.
Endometriosis affects approximately 1 in 10 women of reproductive age, yet diagnosis often takes seven to ten years, largely because the current gold standard requires invasive laparoscopic surgery. 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.
About HerAnova Lifesciences
HerAnova Lifesciences Inc. is a leading life sciences company dedicated to advancing innovative solutions for endometriosis, infertility and other critical unmet needs in 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 globally on its research, development, and commercialization initiatives. For more information, visit www.HerAnova.com.
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