HerResolve Achieves 92% Accuracy in Non-Invasive Endometriosis Diagnosis, Ushering in a New Era of Early Detection

After visiting three Grade A tertiary hospitals and undergoing laparoscopic surgery under general anesthesia, Li Fang (a pseudonym) finally identified the true culprit behind her dysmenorrhea: endometriosis. Over a decade of seeking medical care, she moved from self-doubt—being labeled as “overly sensitive”—to isolation and helplessness as pain stripped away her social life. At this moment, the cloud that had long hung over her was finally dispelled.

According to the latest edition of the Guidelines for Diagnosis and Treatment of Endometriosis, endometriosis is defined by the presence, growth, infiltration, and recurrent bleeding of endometrial tissue (glands and stroma) at sites outside the uterine cavity lining and uterus, subsequently causing pain, infertility, and nodules or masses. In other words, it is a disease that can lead to pain, infertility, and even an increased risk of malignancy. Regrettably, many women in China, like Li Fang (a pseudonym), still lack necessary awareness of this condition and do not have a correct understanding of dysmenorrhea. Consequently, endometriosis is often regarded as a “seriously neglected” chronic disease.

Professor Zhang Xinmei, Director of the Department of General Gynecology and Director of the Second Gynecology Ward (Endometriosis Ward) at the Women’s Hospital, School of Medicine, Zhejiang University, also revealed to VCBeat: “Due to cultural and social backgrounds, as well as perceptions of the disease, Chinese women often choose to endure dysmenorrhea until it becomes unbearable. This has also led to”Endometriosis Exhibits a Highly Pronounced Pattern of Diagnostic Delay。”

Delayed diagnosis further leads to two consequences: first, the incidence rate cannot be accurately estimated. According to the latest edition of the Guidelines for the Diagnosis and Treatment of Endometriosis, approximately 10% of women of reproductive age suffer from endometriosis, meaning that about 190 million women worldwide are affected by this condition. However, Professor Zhang Xinmei stated,The incidence of endometriosis in China may be as high as 40%.

Second,As a progressive disease, delayed diagnosis of endometriosis can lead to impaired female fertility. Studies have shown that endometriosis interferes with embryo implantation and is likely a cause of "unexplained infertility." Furthermore, endometriosis can affect organs such as the ovaries, intestines, and lungs, leading to a range of health issues.“Having practiced for over 30 years, I have witnessed too many such regrets. An earlier diagnosis could have prevented these regrets and even tragedies,” remarked Professor Zhang Xinmei.

Against this backdrop, Professor Zhang Xinmei urges women to seek timely medical attention if they experience abnormal menstrual pain (including dysmenorrhea or chronic pelvic pain), dyspareunia or postcoital pain, cyclically occurring dysuria or defecation pain coinciding with menstruation, or infertility accompanied by at least one of the aforementioned symptoms. Meanwhile, Professor Zhang Xinmei also emphasizes that even women without obvious symptoms should undergo appropriate regular examinations at specialized hospitals.

In addition to the need for greater awareness of endometriosis among women, Professor Zhang Xinmei also pointed out that the limitations of current diagnostic methods are a major cause of delayed diagnosis of endometriosis.

Gynecological examination, imaging studies, biomarker testing, and laparoscopic surgery are currently the primary clinical approaches for endometriosis. Unfortunately, none of these methods can serve as tools for the early diagnosis of endometriosis.

Let's start withGynecological Examination. It primarily faces challenges in accuracy and target population applicability.The reason lies in the fact that gynecological examinations are highly dependent on physicians’ experience and technical skills, leading to issues with accuracy. Furthermore, although triple pelvic examination plays a significant role in diagnosing deep infiltrating endometriosis, where lesions are predominantly located in the posterior pelvis, it is not applicable to patients who have never been sexually active and cannot detect early-stage or superficial lesions.

Let's take another lookImaging examinations, similar to gynecological examinations, also face issues regarding accuracy and applicable populations.Specifically, imaging examinations for endometriosis can be broadly categorized into ultrasound and MRI. The sensitivity of ultrasound and MRI varies depending on the location of the lesions.

For the diagnosis of ovarian endometriomas and deep infiltrating endometriosis, ultrasound examination should be selected, with transvaginal ultrasound being the preferred modality; however, transvaginal ultrasound is not suitable for patients without a history of sexual activity. For endometriosis located in the rectosigmoid colon, transrectal ultrasound may be chosen. However, the Guidelines for Diagnosis and Treatment of Endometriosis (Third Edition) emphasize that transvaginal ultrasound must be combined with the patient’s symptoms, medical history, and/or gynecological examination findings to improve diagnostic accuracy. Furthermore, transrectal ultrasound demonstrates similar sensitivity and specificity to transvaginal ultrasound. In summary, regardless of the ultrasound modality used, achieving high diagnostic accuracy remains challenging.

As for MRI examination, it is mostly used as a diagnostic tool to evaluate the extent of deep endometriosis lesions involving the intestine, bladder, or ureter. For suspected endometriosis with existing clinical symptoms or signs, MRI is not recommended as the first-choice examination method.

Moreover, during the interview, Professor Zhang Xinmei directly addressed a critical issue by explaining why imaging examinations cannot serve as the primary method for the early diagnosis of endometriosis. The reason is thatIn cases of early-stage endometriosis, imaging studies typically reveal no specific findings. In other words, imaging examinations are unable to detect early lesions of endometriosis.

andBiomarker testing currently primarily focuses on CA-125 testing; however, elevated CA-125 levels are not specifically associated with endometriosis.Therefore, it cannot serve as a standalone method for the early diagnosis of endometriosis.

Finally, let us examine laparoscopy, which is hailed as the “gold standard” for the diagnosis of endometriosis. Undoubtedly,Laparoscopy, which allows for direct visualization of pelvic lesions and biopsy confirmation, offers high diagnostic accuracy. However, due to the uneven distribution of ectopic tissue within the pelvis, there remains a certain risk of misdiagnosis. Furthermore, laparoscopy is an invasive surgical procedure associated with inherent risks and higher costs.Therefore, using laparoscopic surgery for the early diagnosis of endometriosis would be akin to “using a sledgehammer to crack a nut.”

In this regard, during the interview, VCBeat asked Professor Zhang Xinmei, “As a physician, what do you envision as the ideal tool for the early diagnosis of endometriosis?” Professor Zhang Xinmei’s response provided a highly concise summaryClinical Demand for Early Screening Methods for Endometriosis: Precision, Timeliness, and Non-Invasiveness.

“Precision” and “timeliness” are clinicians’ requirements for the accuracy and efficiency of screening tools, while “non-invasiveness” aims to enhance public acceptance and thereby increase willingness to undergo testing. With clinical needs clearly defined, and faced with a vast patient population enduring significant overt and covert suffering, a number of companies have swiftly responded, committed to translating clinical concepts into tangible products to meet these needs and prevent further regrets. Hekaiwei Life Sciences is a representative example.

Co-founded by a team of seasoned entrepreneurs and former executives from multinational corporationsHeKaiWei Life Sciences is an innovative medical technology company focused on women's health, dedicated to integrating diagnostics, pharmaceuticals, devices, and data to provide one-stop solutions for the field of obstetrics and gynecology.

In March 2023, HeKaiWei Life Sciences completed seed and seed-plus financing rounds totaling over $10 million, aiming to accelerate the commercialization of its product portfolio, including non-invasive molecular diagnostic products for endometriosis. Two years later,Hekewei Life Sciences officially announced that its innovative product, HerResolve—which enables the diagnosis of endometriosis using only a peripheral blood sample—has completed global LDT validation and was first launched in the United States on March 28.

This is a breakthrough non-invasive diagnostic product for endometriosis based on peripheral blood, launched in the U.S. market as a Laboratory Developed Test (LDT). By providing clear “negative/positive” results, it helps women obtain accurate and rapid diagnoses, thereby avoiding long-term misdiagnosis and unnecessary surgical interventions. Furthermore, through more accurate early diagnosis, the product empowers physicians to develop personalized treatment plans, making “early detection and early treatment” of endometriosis a reality.

Specifically, HeKaiWei Life Sciences’ HerResolve endometriosis diagnostic product selects highly specific and stable miRNA biomarkers through research on molecular pathways associated with endometriosis to ensure testing reliability, and further enhances diagnostic accuracy by leveraging AI-driven algorithms to process complex data.

According to Hekewei Life Sciences, the diagnostic accuracy of this product reaches 92%, with a sensitivity of 90%, significantly outperforming existing detection methods.Meanwhile, HeKaiWei Life is also committed to optimizing testing processes and enhancing laboratory automation to deliver precise test results within a short timeframe. Furthermore, the collection of peripheral blood has, to some extent, alleviated patient discomfort and risks, thereby improving the accessibility of testing.

High accuracy, short detection time, and non-invasiveness—all features of HerResolve by Hekewei Life Sciences align with the clinical demands proposed by Professor Zhang Xinmei.

According to HeKaiWei Biosciences, leveraging robust evidence-based medical data, the company is establishing in-depth collaborations with professional institutions specializing in gynecology, reproductive medicine, health examination centers, and pharmaceutical enterprises for its HerResolve non-invasive endometriosis diagnostic product. By utilizing real-world study data, it will provide specialized testing services for women experiencing significant pelvic pain, particularly those with fertility desires or a family history of endometriosis.

In the future, while continuing to optimize its existing diagnostic product, HerResolve, Hekewei Biosciences will further develop testing tools capable of precisely staging endometriosis, thereby providing clinicians with more comprehensive evidence for formulating personalized treatment plans. Notably, the company’s team is exploring a novel, undisclosed protein biomarker that may play a role in alleviating endometriosis-associated pain.

Meanwhile, HeKaiWei Life Sciences will enhance product awareness among professionals through professional academic conferences and publications in academic journals. The company will also actively seek collaborations with relevant institutions to boost public awareness of endometriosis and increase the acceptance and visibility of non-invasive testing technologies via popular science articles, books, and social media channels. Furthermore, HeKaiWei Life Sciences will leverage its professional technical and customer service teams to provide specialized product consultation and testing guidance for patients, physicians, and partners.

In addition to collaborating with hospital-affiliated laboratories in the Chinese market and pursuing registration filings for IVD reagents, Hekewei Life Sciences has simultaneously initiated preparation for FDA 510(k) submissions in the U.S. market.HerResolve is poised to become the world’s first FDA-cleared non-invasive peripheral blood test for endometriosis.

In addition to HerResolve, Hekaiwei Life Sciences has built a comprehensive product portfolio covering the entire reproductive health lifecycle. For patients undergoing in vitro fertilization (IVF), the company has launched HerRecepta, an endometrial receptivity analysis that helps identify each patient’s personalized “window of implantation” to enable precise embryo transfer; and HerBiota Complete, a uterine cavity microbiome test that analyzes all bacteria within the uterine cavity to optimize conditions for embryo implantation. These innovative products will create synergies with HerResolve, collectively providing precision solutions for the field of reproductive health.

At the conclusion of the interview, Professor Zhang Xinmei shared with VCBeat his vision for the diagnosis and treatment of endometriosis: In terms of examination, diagnostic tools for endometriosis are bound to evolve toward greater precision and non-invasiveness. Furthermore, as non-invasive diagnostic technologies continue to advance, their costs will also decrease. Building on this foundation, coupled with improved public awareness of endometriosis, large-scale popularization of early screening for the condition will inevitably be achieved in the future. “If cervical cancer can undergo widespread, large-scale screening across China, then why not endometriosis?”

In terms of treatment, Professor Zhang Xinmei believes that with the further advancement of new drug development technologies, the future management of endometriosis will inevitably trend toward “a decreasing proportion of surgical interventions and an increasing proportion of pharmacological therapies.” Moreover, the pharmacological management of endometriosis may become similar to that of chronic diseases such as hypertension, requiring only regular oral medication.

Achieving this goal naturally requires the support of enterprises. HeKaiWei Life Sciences stated, “Under the influence of multiple factors such as modern lifestyles, marriage and childbearing patterns, environmental conditions, and stress, modern women face a higher risk of endometriosis. However, public awareness of endometriosis remains generally insufficient. Coupled with the complex etiology of the disease, the lack of early diagnostic tools, and variations in physicians’ specialized experience, significant challenges are posed to early diagnosis and treatment, as well as to the preservation of women’s future fertility. The registration cycle for in vitro diagnostic (IVD) reagents and the updating of clinical guidelines also require considerable time. Nevertheless, HeKaiWei firmly believes that promoting evidence-based medicine can facilitate the adoption of new technologies and enhance patients’ understanding of chronic disease management. We will join hands with patients, physicians, government agencies, and industry partners to collectively overcome these challenges.”