June 10, 2025 | Endometriosis occurs when tissue similar to the lining of the uterus grows outside of the uterus. The condition is painful, can impede fertility, and is difficult to diagnose. But a host of new tools seek to improve diagnostics and treatment for the condition.
Cicero Diagnostics, a Nevada-based company, has announced the release of its MyReceptiva endometriosis detection test, designed to identify patients who are likely to have the condition and would benefit from consulting with an endometriosis specialist. Meanwhile, Boston-based Heranova Lifesciences revealed the Laboratory Developed Test (LDT) validation and U.S. launch of HerResolve, a blood test that will initially be available through select clinical centers.
On the treatment side, EDAP, a company headquartered in France, has indicated that its Focal One Robotic HIFU System received CE Mark certification for the treatment of deep infiltrating endometriosis. In other news, New Jersey-based Lisata Therapeutics has entered into a sponsored research agreement with the University of Cincinnati to explore the use of its novel product candidate, certepetide, in combination with bevacizumab for the treatment of endometriosis.
Diagnostic Difficulties and Delays
Endometriosis occurs when tissue similar to the lining of the uterus grows outside of the uterus. Although pelvic exams and imaging tests are used to help diagnose the condition, surgical laparoscopy is currently the only way to arrive at a definitive diagnosis.
“On the patient side, it’s very hard for women to know what is out of the ordinary,” said Christopher Jackson, President & CEO of Cicero Diagnostics. Issues like period pain, painful intercourse, or painful bowel movements can become debilitating. But because there is nothing to compare it to, women often normalize that discomfort.
Beyond that, the variability in symptoms and the brief time doctors have with patients during a typical annual visit make it challenging to identify those who should seek follow-up care. “And if women don’t speak up, it just goes on and on,” he told Diagnostics World.
Endometriosis is estimated to affect roughly 1 in 10 women of reproductive age worldwide. Despite its prevalence, the condition has traditionally been challenging to diagnose promptly, often taking several years to arrive at a correct diagnosis. This delay is due to a variety of factors, such as a lack of endometriosis awareness, symptom overlap with other conditions, and a reluctance to pursue surgery.
It is not uncommon for doctors to prescribe medicine that focuses on the symptoms rather than determining the underlying cause of the problems, Jackson explained. As a result, many women are treated for conditions like irritable bowel syndrome instead of undergoing a full exam.
And although laparoscopy can lead to a definitive diagnosis, few women opt for surgery right off the bat. Ultimately, it’s a matter of having the right clinician recognize the signs and getting a patient to the right place to achieve a diagnosis, he added.
Less Expensive Test Option Aims to Increase Accessibility
Jackson said the MyReceptiva test is meant to help women understand the source of undiagnosed pelvic or abdominal pain and identify endometriosis as the cause of infertility or recurring pregnancy loss. It provides a first step for early detection that can help guide treatment or surgical referrals.
“The testing itself came from our ability to license the patent from the University of North Carolina on the original research by Dr. Bruce Lessey, who is not only a reproductive endocrinologist—one of the doctors who does IVF and sees patients for infertility—but also a clinical researcher,” Jackson explained.
“His fascination was with what is going on in the uterine lining in these women that are having challenges of getting pregnant or staying pregnant, even if they’re going through IVF,” he continued. Lessey explored various proteins and markers to determine if there is something present in these women that is not present in women who are not experiencing difficulties getting pregnant. Through this line of work, the isolation of a protein called BCL6 was achieved.
The MyReceptiva test is based on the presence of the BCL6 protein and is performed from an endometrial biopsy. This procedure can be carried out during a routine gynecological visit, typically seven to 10 days after ovulation. The sample is then sent overnight to the company’s laboratories.
“The tissue is processed and then stained for the BCL6, and we’ll report out a positive/negative based on a formula for establishing a cut off for normals versus women that are expressing the protein,” Jackson explained, “and we get results back in about five or six days to the practice and physician.”
The test builds upon roughly eight years of use by over 450 fertility centers in the United States (under the brand name ReceptivaDx) to identify endometriosis in women who have experienced failed IVF and pregnancy loss. According to the company, over 40,000 tests have been performed to date, and the test has demonstrated a sensitivity and specificity of over 90%.
The company’s recent announcement is primarily about making the less expensive version of the test available to women who would otherwise never approach a fertility center, Jackson explained. Some may not have the financial means or insurance coverage, he explained, whereas others may avoid fertility centers for religious or other reasons.
“We just wanted to make it more accessible, and that’s the whole purpose of MyReceptiva,” he said. The collection kit can be purchased online and taken to an OB-GYN. In addition to the testing itself, Cicero Diagnostics supports a network of endometriosis specialists and offers an app to guide women through the entire process.
In terms of limitations, “our biggest challenge is making sure people collect the sample at the right time,” Jackson said. “We need a sample collected in the luteal phase of the menstrual cycle, which is seven to 10 days after ovulation. “It’s a very reliable test,” Jackson added, but “we use the word detection—not diagnosis. We understand what our role is. We can’t get a diagnosis. But in lieu of going to surgery, it’s great information up front.”
There are a couple of limiting factors associated with this test that people need to be aware of and adhere to, he explained. A woman on birth control would need to go off of birth control and have at least one period before taking the MyReceptiva test, for example. Other limitations include fallopian tube blockages and bacterial infections, which can impact test results.
Looking ahead, Cicero Diagnostics continues to invest in research and development efforts aimed at creating next-generation diagnostic tools for this disease. The company is exploring new assays that would use a blood or saliva sample to simplify the collection process, Jackson said. Still, the biopsy test remains an offering that he believes will play a significant role for some time, even as research shifts toward newer technologies and approaches.
Blood Test Launched with Future Plans to Expand
Heranova’s HerResolve test uses miRNA biomarkers and advanced bioinformatics to yield an actionable positive or negative result. The test relies on a blood sample, explained Farideh Bischoff, chief medical officer and head of diagnostics at Heranova Lifesciences. From that blood, the serum is isolated and used as the sample type to test a number of biomarkers circulating in the serum sample at any given time.
Quantitative PCR (qPCR) is used to measure the levels of biomarkers present in the serum sample, which are compared to the levels found in women with and without endometriosis to demonstrate whether the detected levels correlate with disease presence.
Artificial intelligence and machine learning are used to train a model that learns how to interpret the levels of each of these biomarkers and arrive at an actionable positive or negative test result. “The important piece is that our test is validated against the gold standard, which is not just laparoscopy but laparoscopy with histology, meaning the tissue that is biopsied,” Bischoff told Diagnostics World. Because of this, the level of confidence in the test results is high, she added.
Bischoff highlighted some of the shortcomings of traditional approaches, explaining that laparoscopy does not detect all cases of this disease. In many instances, women undergo surgery for suspected endometriosis, but nothing is found to biopsy, which can lead to questions of whether something was missed or whether they are truly negative. “And histology is only as good as your ability to be able to obtain a biopsy to then perform the gold standard of histopathology,” she said.
Furthermore, every time surgery is performed a woman’s reproductive health can be compromised because of the scar tissue and other issues that can occur, she continued, so for some women avoiding surgery is important, either because they are attempting to get pregnant or they have had previous surgeries and do not want to undergo another one.
“Our non-invasive test, side by side with gold standard, has shown to be now 92% accurate, but remarkably with a much higher specificity, meaning when we detect it, our confidence that it’s correct is very high, and that confidence is today greater than 92%,” she said.
Bischoff said she believes the HerResolve test is “equivalent and perhaps superior” to laparoscopy, which she believes will be proven through the FDA study that is currently underway to demonstrate performance across a large population of US-based patients and women from other parts of the world.
In terms of limitations, Bischoff noted that once a blood sample is drawn, it must be processed within a certain timeframe. Another notable issue (that she said is currently being addressed) is determining when to perform an analysis. It is known that endometriosis is driven by hormones typically activated during a menstrual cycle; therefore, many of the biomarkers used to detect the disease are also menstrual phase-specific.
“So what we have undertaken is verifying that the markers we use—the biomarkers we use—correlate with all the representative phases of the menstrual cycle so that we’re able to address all cases, irrespective of when the blood is drawn,” she explained.
To carry out the performance study meant to obtain FDA clearance for the HerResolve product, Heranova has collaborated with several clinical centers in the United States and abroad to collect patient samples based on specific criteria. Those clinical sites are now becoming commercial sites that will utilize the test for their patients. “By doing that, we’re basically ensuring that we’re working with sites who know how to use the test, how to collect the sample, and how to then apply the information that they’ve obtained from the result to patient management,” she said.
The second phase is to then expand to other large network hospitals, such as the Mayo Clinic or Cleveland Clinic, where they have a patient population and minimally invasive surgeons who often want to know whether a patient has endometriosis before performing a surgical procedure.
“Once we are with these larger centers, then we will open that up nationally,” Bischoff added. The goal is to roll out diagnostic tests at a pace that allows the lab to become fully equipped and integrated into the workflow. As the clinical community learns more, the demand is expected to increase. “Then we’ll be able to expand to address the demand and provide the test to those who want to make it available.”
Paul Nicolaus is a freelance writer specializing in science, nature, and health. Learn more at www.nicolauswriting.com.