The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis.
Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.
Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve.
5 Strategic Steps To Bring Your Email Security Up To Today’s Standards
This report highlights what Paubox says is a broken infrastructure at the heart of this issue, exposing millions to preventable risks.
When a woman has endometriosis, tissue that typically grows inside the uterus ends up growing outside of it, creating lesions in the peritoneal cavity. This abnormal tissue growth can envelop the ovaries and fallopian tubes, as well as negatively impact nearby organs like the bladder and bowel. The disease typically causes debilitating pain and is a key driver of female infertility.
The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis.
The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.
The Role of Consultants in Tackling Healthcare Expenses
To ensure effective cost mitigation, employers can’t wait for the market to adjust — they have to punch first.
This means that Heranova’s test could potentially replace the diagnostic function of laparoscopy, thus reserving surgical intervention solely for therapeutic purposes, she explained.
The test aims to shorten diagnostic delays and allow for more proactive disease management before severe symptoms emerge. It also offers benefits for women who are experiencing infertility challenges, Bischoff noted.
“Women with infertility often have endometriosis, and surgery is often not an option for these women. Having [a noninvasive test] would be ideal for IVF patients because these women are trying to get pregnant — and any risk that could reduce their pregnancy likelihood is not wanted. That’s a utility of the test — to avoid surgery in order to preserve fertility,” she stated.
In the future, Bischoff said Heranova hopes to develop a nonsurgical therapeutic for endometriosis as well. The startup is in the early stages of beginning this process and is currently identifying molecules to work with, she said.
In addition to the LDT validation it has already earned, Heranova is also working to secure FDA clearance for its diagnostic test.
“This is in order to get to an in vitro diagnostic. An in vitro diagnostic would then create a kit that can then be distributed to hospitals around the world, and [HerResolve] becomes far more attractive to the clinical centers that do this. But we will cover both — meaning we’ll have a testing lab as well as distribute products that allow clinicians to do the testing in their hospital,” Bischoff explained.
But Heranova is not the only company hoping to be the first to bring the first FDA-cleared noninvasive endometriosis diagnostic to the market.
For example, there is Hera Biotech, a San Antonio-based startup developing a quick in-office test that relies on causative genetic links to endometriosis.
Bischoff also highlighted French company Ziwig, which is creating a saliva-based test, as a competitor.
“They use next generation sequencing, which adds cost and turnaround time. So their tests can take two to three weeks to analyze and have a result,” she remarked.
She added that in her view, Heranova’s test stands out even further because it validates itself against histology — not just the visual detection of lesions from laparoscopy.
Heranova, which was founded in 2022, has raised about $13 million in seed funding. The startup is currently working on its Series A round, with a target of an additional $15 million, said Penny Wan, the company’s co-founder and chairwoman.
Photo: Natali_Mis, Getty Images