The test demonstrates diagnostic accuracy comparable to surgical gold standard, supporting earlier clinical decision-making in reproductive medicine.
HerAnova Lifesciences has launched commercial availability of HerResolve, a blood-based test developed to detect endometriosis, across a network of in vitro fertilization (IVF) and reproductive medicine centers in the US.
Following completion of Laboratory Developed Test (LDT) validation, HerResolve is now being used by reproductive endocrinologists and OB-GYNs at leading IVF centers, including Reproductive Partners Medical Group across Southern California and CNY Fertility locations nationwide.
The company says the test addresses a diagnostic gap in women’s health. Endometriosis affects one in 10 women of reproductive age, yet diagnosis often takes years and may require invasive surgical procedures. During that time, patients experience prolonged uncertainty, delayed treatment, and significant impacts on quality of life.
Comparable Accuracy to Surgical Diagnosis
HerResolve has demonstrated diagnostic accuracy concordant with histology-confirmed laparoscopy, the current gold standard for diagnosing endometriosis. In validation studies pairing blood-based, multi-omic molecular findings with corresponding surgical histology, the test showed strong concordance with tissue-based diagnosis.
The test aids in endometriosis diagnosis within a multimodal management approach that includes clinical evaluation, imaging, medical therapy, and surgery. By delivering clinically relevant biological insight, the test supports physician decision-making and helps guide referrals, treatment planning, and next diagnostic steps.
“In fertility care, timing matters,” says Carrie Wambach, MD, board-certified in obstetrics and gynecology and reproductive endocrinology and infertility at Reproductive Partners Medical Group, in a release. “HerResolve helps us personalize fertility plans and move to the most effective treatment in a timely manner. That clarity is especially valuable when counseling patients who are already navigating an emotional and time-sensitive fertility journey, providing added confidence at critical decision points.”
Supporting Reproductive Medicine Workflows
The clinical settings where HerResolve is being implemented represent points of care where endometriosis commonly intersects with infertility, pelvic pain, and complex reproductive decision-making, according to a release from the company, which notes that, despite advances in imaging and clinical awareness, accessible non-invasive tools to support evaluation have remained limited.
“HerResolve helps us evaluate patients with suspected endometriosis using a non-invasive approach,” says James D. Kondrup, MD, board-certified OB-GYN and minimally invasive gynecologic surgeon at CNY Fertility, in a release. “It supports clinical decision-making by helping align surgical planning and fertility treatment timing, with the goal of preparing patients as effectively as possible before IVF.”
The test provides earlier detection capabilities, including in patients who may not yet realize endometriosis is contributing to their symptoms or fertility challenges.
“Endometriosis is often recognized only after years of symptoms, uncertainty, or unsuccessful treatment,” says Farideh Bischoff, PhD, chief medical officer and head of diagnostics at HerAnova Lifesciences, in a release. “By bringing HerResolve into reproductive medicine settings, we are detecting endometriosis earlier, including in patients who may not yet realize it is contributing to their symptoms or fertility challenges. Earlier insight can mean earlier answers, more timely care, and better patient outcomes.”
HerAnova expects to continue expanding access to HerResolve across additional reproductive medicine and gynecology practices while building clinical evidence and educational resources for both physicians and patients.
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