Endometriosis is a chronic neuroinflammatory disorder affecting over 190 million women worldwide. Characterized by the growth of endometrial-like tissue outside the uterus, the condition manifests as peritoneal, ovarian, or deep lesions, most commonly in the pelvis. Patients experience persistent pelvic pain, often worse during menstruation, as well as fatigue, gastrointestinal and urinary symptoms, mood disorders, and in many cases, infertility. Studies estimate that 30-50 percent of patients with endometriosis face difficulties conceiving.
Despite its prevalence, diagnosis remains challenging. On average, it takes 7–9 years from the first symptoms to achieve a definitive diagnosis, largely due to overlapping symptoms with other conditions, such as irritable bowel syndrome or bladder pain syndrome, and low awareness among patients and primary care providers.
Traditional diagnosis relies on imaging and invasive laparoscopic surgery, but both approaches have significant limitations. Imaging often misses superficial lesions and adhesions, while laparoscopy is extremely invasive, carries surgical risks, and may still fail to provide a definitive diagnosis without confirmatory biopsies. Now, a multi-omic, blood-based assay developed by HerAnova Lifesciences can provide a fast, non-invasive “rule-in” test for endometriosis. The test, known as HerResolve, was commercially launched in December 2025 as a lab-developed test, and is now available at select IVF and reproductive medicine centers across the US.
A systemic disease demands a systemic approach
Endometriotic lesions can occur throughout the body, and symptoms often do not correlate with lesion size, location, or surgical stage. Some patients with minimal visible disease experience debilitating pain, while others with extensive lesions may only report relatively mild symptoms. This disconnect has complicated both diagnosis and disease management for decades.
Adding to the challenge is the profound heterogeneity of endometriosis. The condition presents in multiple subtypes, progresses differently across individuals, and is influenced by a complex interplay of inflammatory, hormonal, genetic, and immunologic factors.
In light of this, HerAnova focused on identifying disease-associated biomarkers circulating in the blood — an approach that has transformed diagnostics in fields such as oncology and prenatal medicine.
“Blood allows us to evaluate endometriosis as a whole-body disease,” Farideh Bischoff, Chief Medical Officer at HerAnova, explained to DDN. “It’s not confined to the reproductive organs or the pelvic cavity. The biology of endometriosis can be reflected systemically, which makes blood an appropriate and practical sample type.”
In addition to using blood, HerAnova employed a multi-omic approach, measuring signals across different biological layers. Bischoff explained that the first phase of the project began about two years ago, focusing on the collection of well-characterized patient samples for biomarker discovery. “We were careful not to introduce bias in the samples we collected for validation and development,” said Bischoff. “Our goal was to reflect the full heterogeneity of endometriosis in the samples we used to develop and validate the test.”
Once the team obtained a sufficient number of samples with concordant findings from both laparoscopy and pathology evaluation, they conducted sequencing-based discovery, comparing women with endometriosis to those without while accounting for disease stage, lesion type, and prior treatments. This analysis identified biomarkers that were differentially expressed between the two groups. “What really amazed me was how reliably we could identify markers that were clearly distinct — truly night and day differences,” she said. “Without machine learning, spotting these patterns would have been extremely difficult.”
A validated approach
These candidate biomarkers were then used to train a machine learning algorithm on a cohort of 218 patients. The trained model was subsequently tested on an independent validation cohort, producing highly predictive results that were recently published in the Journal of Minimally Invasive Gynecology.
The study was designed as a multi-center, case-control investigation to evaluate the accuracy of HerResolve in detecting endometriosis across menstrual cycle phases and in comparison with standard imaging. Peripheral blood samples were analyzed for a combination of three microRNAs, three protein biomarkers, one steroid hormone, as well as patient age and body mass index.
In the independent validation cohort, HerResolve demonstrated strong predictive performance, achieving an area under the curve of 0.944, with 80 percent sensitivity, and 97.5 percent specificity. Additionally, performance remained robust across menstrual cycle phases.
Most excitingly, the blood-based assay identified 61.5 percent of histologically confirmed endometriosis cases that had been missed by transvaginal ultrasound and/or MRI. “Honestly, we didn’t anticipate this at all. It was only after performing a sub-analysis that we realized a substantial number of patients had lesions that standard imaging had completely missed,” Bischoff said. “Many of these were earlier stage cases and cases that have peritoneal disease, which is one of the more difficult types to detect because of the location and size in the body.”
Earlier diagnosis, better outcomes
The study showed that this approach could improve early detection and possibly identify patients at much earlier stages of disease, including adolescents and young adults who often experience symptoms long before a formal diagnosis.
Endometriosis often begins in adolescence, yet many patients go years without recognition. This is partly because early symptoms — severe dysmenorrhea, ovulatory pain, gastrointestinal issues, and fatigue — are often minimized as “normal” menstrual pain. “Patients often feel dismissed when imaging is negative,” said Bischoff. “But that’s not right — by delaying diagnosis, you’re essentially allowing the disease to progress unchecked.”
These delays can worsen symptoms, reduce quality of life, and increase healthcare burden. “By the time a young woman reaches early adulthood, a decade or more of disease progression may have already occurred. The real goal, then, is to have a test that can be offered at the very first signs of symptoms, so intervention can happen much earlier.”
Empowering clinicians and patients
“We need to educate, and we need to educate earlier,” said Bischoff. “Physicians, too, must be aware — primary care doctors and OB-GYNs are often the first point of contact, but, unfortunately, awareness and education are really lacking for endometriosis.”
Tools like HerResolve demonstrate how combining multi-omic biomarkers with machine learning can support a more accurate, non-invasive approach to diagnosis. By complementing imaging and helping guide clinical decision-making, this type of approach could reduce diagnostic delays, inform earlier interventions, and ultimately improve outcomes for women navigating this complex, often misunderstood condition.
